[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"als\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:als":687},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,52,107,134,161,185,210,233,257,283,305,327,348,364,396,419,451,474,495,524,550,574,604,626,643],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100392965",false,"NCT04396873","PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease","Phase 1 Study: PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease","* INCLUSION CRITERIA:\n\nPatients: In order to be eligible to participate in this study, patients must meet all of the following criteria:\n\n1. Aged 18 or older.\n2. Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document.\n3. Have been diagnosed by a neurologist or psychiatrist with MCI, ALS, PD, or an adult onset neurodegenerative dementia, such as AD (including amyloid negative subjects), FTD, corticobasal syndrome, or Huntington s disease.\n4. Be in good general health as evidenced by medical history and physical examination.\n5. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n6. Agree to adhere to the lifestyle considerations.\n\nHealthy volunteers: In order to be eligible to participate in this study, healthy volunteer subjects must meet all of the following criteria:\n\n1. Aged 18 or older.\n2. Female participants of childbearing potential must be using a medically acceptable means of contraception\n3. Able provide informed consent.\n4. Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n5. Be enrolled in 01-M-0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17-M-0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies\n6. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n7. Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nBoth patients and healthy volunteers who meet any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \\>1.3 mg\u002FdL\n2. Subjects should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAID) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month.\n3. Contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding.\n4. Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities.\n5. Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n6. Are unable to travel to the NIH.\n7. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n8. Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the patient and\u002For caregiver during the screening visit.\n9. Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n10. Participants should not be under treatment with Aduhelm, nor should they have been treated in the past.\n11. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye).\n12. Pregnancy\n13. HIV infection\n14. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.",true,"ALL","18 Years","99 Years",{"count":21,"type":22},184,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Background:\n\nAbout 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation.\n\nObjective:\n\nTo learn whether COX-1 and\u002For COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers.\n\nEligibility:\n\nAdults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181.\n\nDesign:\n\nParticipants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured.\n\nParticipants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs.\n\nParticipants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan.\n\nParticipants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.",[28,29,30,31,32],"Parkinson's Disease","Dementia","Alzheimer's Disease","ALS","Mild Cognitive Impairment",[34,35,36,29,37,31,38],"PET Imaging","PD","Inflammation","Cyclooxygenase-2","MCI","RECRUITING","2026-07-01",{"date":42,"type":43},"2026-07-02","ACTUAL",{"date":45,"type":43},"2021-08-17",{"date":47,"type":22},"2030-10-03",{"name":49,"class":50},"National Institute of Mental Health (NIMH)","NIH",1,{"id":53,"slug":4,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":89,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100270060","NCT02795052","Neurologic Stem Cell Treatment Study","Neurologic Bone Marrow Derived Stem Cell Treatment Study","NEST","Inclusion Criteria:\n\n1. Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.\n2. Be at least 6 months post-onset of the disease.\n3. If under current medical therapy (pharmacologic or surgical treatment) for the condition be considered stable on that treatment and unlikely to have reversal of the associated neurologic functional damage as a result of the ongoing pharmacologic or surgical treatment.\n4. In the estimation of Dr. Weiss and the neurologists have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.\n5. Be over the age of 18 and capable of providing informed consent.\n6. Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.\n\nExclusion Criteria:\n\n1. All patients must be capable of an adequate neurologic examination and evaluation to document the pathology. This will include the ability to cooperate with the exam.\n2. Patients must be capable and willing to undergo follow up neurologic exams with the sub-investigators or their own neurologists as outlined in the protocol.\n3. Patients must be capable of providing informed consent.\n4. In the estimation of Dr. Weiss the BMSC collection and treatment will not present a significant risk of harm to the patient's general health or to their neurologic function. .\n5. Patients who are not medically stable or who may be at significant risk to their health undergoing the procedure will not be eligible.\n6. Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post treatment.",{"count":60,"type":22},500,[62],"NA","This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1\u002F3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http:\u002F\u002Fmdstemcells.com\u002Fnest\u002F",[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,31,81,82,83,84,29,85,86,87,88],"Neurologic Disorders","Nervous System Diseases","Neurodegenerative Diseases","Neurological Disorders","Stroke","Traumatic Brain Injury","Cadasil","Chronic Traumatic Encephalopathy","Cerebral Infarction","Cerebral Ischemia","Cerebral Stroke","Cerebral Hemorrhage","Parkinson","Multi-System Degeneration","MSA - Multiple System Atrophy","Progressive Supranuclear Palsy","Amyotrophic Lateral Sclerosis","Neuropathy","Diabetic Neuropathies","Alzheimer Disease","Frontotemporal Dementia","Lewy Body Disease","Cognitive Impairment","Lewy Body Variant of Alzheimer Disease",[90,91,69,70,92,93,82,94,74,87,29,95],"Neurologic Disease","Cerebral Vascular Accident","Multiple Sclerosis","Parkinsons Disease","Diabetic Neuropathy","Neurodegeneration","2026-06-24",{"date":98,"type":43},"2026-06-26",{"date":100,"type":43},"2016-06",{"date":102,"type":22},"2028-07-31",{"name":104,"class":105},"MD Stem Cells","INDUSTRY",3,{"id":108,"slug":4,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":51},"100555426","NCT06511934","Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)","Intuitive, Complete Neural Control of Tablet Computers for Communication","BG-Tablet-01","Inclusion Criteria:\n\n* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders\n* Complete or incomplete tetraplegia (quadriplegia)\n* Must live within a three-hour drive of the Study site\n* Prior enrollment in BrainGate2 clinical trial (NCT00912041)\n\nExclusion Criteria:\n\n* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n* Chronic oral or intravenous steroids or immunosuppressive therapy\n* Other serious disease or disorder that could seriously affect ability to participate in the study\n\n(There are additional exclusion criteria)","80 Years",{"count":116,"type":22},6,[62],"People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.",[120,31,121,122,123],"Brainstem Stroke","Tetraplegia","Spinal Cord Injuries","Cervical Spinal Cord Injury","2026-06-22",{"date":126,"type":43},"2026-06-25",{"date":128,"type":43},"2024-07-22",{"date":130,"type":22},"2027-07-30",{"name":132,"class":133},"Leigh R. Hochberg, MD, PhD.","OTHER",{"id":135,"slug":4,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":139,"enrollmentInfo":140,"targetDuration":142,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100513482","NCT05966038","ALS\u002FMND Natural History Study Data Repository","Inclusion Criteria:\n\n* A clinical diagnosis of El Escorial of suspected, possible, probable, or definite ALS or\n* Other motor neuron disorders, including but not limited to Spinal-Bulbar Muscular Atrophy (SBMA, Kennedy's disease), Spinal Muscular Atrophy (SMA), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), and Progressive Bulbar Palsy (PBP)\n\nExclusion Criteria:\n\n* Disease does not meet criteria for any motor neuron disorder","90 Years",{"count":141,"type":22},5000,"5 Years","OBSERVATIONAL","This is a data repository for multi-site multi-protocol clinic-based Natural History Study of ALS and Other Motor Neuron Disorders (MND).\n\nAll people living with ALS or other MNDs who attend clinics at the Study hospitals (sites) are offered to participate in the Study.\n\nThe Sites collect so-called Baseline information including demographics, disease history and diagnosis, family history, etc. At each visit, the Sites also collect multiple disease-specific outcome measures and events. The information is captured in NeuroBANK, a patient-centric clinical research platform.\n\nThe Sites have an option to choose to collect data into 20+ additional forms capturing biomarkers and outcome measures. Captured data after its curation are anonymized (all personal identifiers and dates are being removed), and the anonymized dataset is shared with medical researchers via a non-exclusive revocable license.\n\nFunding Source - Biogen, Inc.; Mitsubishi Tanabe Pharma America; FDA OOPD.",[31,146,147,148,149,150],"PLS","MND (Motor Neurone DIsease)","Kennedy Disease","PMA - Progressive Muscular Atrophy","PBP - Progressive Bulbar Palsy","2026-05-18",{"date":153,"type":43},"2026-05-20",{"date":155,"type":43},"2015-04-01",{"date":157,"type":22},"2030-12-31",{"name":159,"class":133},"Massachusetts General Hospital",18,{"id":162,"slug":4,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":166,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":164,"conditions":170,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100634721","NCT07543367","INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study","Inclusion Criteria:\n\n* Able to provide informed consent to participate in the study.\n* Diagnosis of ALS, with bilateral upper-limb paresis.\n* ALS must be refractory to treatment and have been present for a minimum of six months.\n* Aged 22 years or older.\n* Life expectancy greater than 12 months post-implantation.\n* Preserved precentral gyrus assessed using CT.\n* Suitable vascular anatomy assessed using CT venography.\n* Suitable anatomy for subcutaneous pocket creation.\n* Able to undergo anesthesia.\n* Willing and able to comply with all investigational requirements, including clinical testing visits and training visits in the home.\n* Caregiver(s) willing and able to facilitate study visits, including visits to the study site and in the home, and BCI use outside of study visits (e.g., device charging).\n* Patient and caregiver fluent in English.\n* Suitable home environment for BCI training.\n\nExclusion Criteria:\n\n* Active infection or unexplained fever in the 48 hours prior to informed consent.\n* Major psychiatric disorder that may adversely impact the participant's safety or study compliance, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.\n* Diagnosis of ALS-FTD or another dementia.\n* Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).\n* Known allergy to patient-contacting materials included in the implanted device.\n* Contraindication to angiographic imaging or iodine contrast media.\n* History of central venous sinus thrombosis.\n* Recent history of new venous thromboembolic event (in the 6 months prior to implant), recurrent history of venous thromboembolic disease, or hypercoagulable state.\n* Contraindication to antithrombotic therapy.\n* Participant is at substantially increased risk of infection, including immunocompromised status, recurrent or chronic infection, or poorly controlled diabetes mellitus.\n* Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.\n* Pregnant or breast feeding.\n* Patients who are currently enrolled in any other clinical trial that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements.\n* Any other disease or disorder that could significantly affect participation in the study. Examples may include corrected vision insufficient for viewing computer screens or hearing insufficient for following verbal instructions, which might impact the participant's ability to participate in BCI training and testing.","22 Years",{"count":168,"type":22},10,[62],[171,172,173,174,31],"Neurological Disorder","ALS (Amyotrophic Lateral Sclerosis)","Motor Neuron Disease","ALS - Amyotrophic Lateral Sclerosis","2026-05-07",{"date":177,"type":43},"2026-05-11",{"date":179,"type":22},"2026-04",{"date":181,"type":22},"2029-12",{"name":183,"class":105},"Synchron, Inc.",5,{"id":186,"slug":4,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":106},"100572572","NCT06735014","Multicenter ALS Imaging Study","Multicenter Longitudinal Imaging in ALS for Disease Biomarker Development","For participants with ALS:\n\n* \\\u003C 36 months since onset of symptoms\n* Definite, probable, lab supported-probable or possible ALS by El Escorial criteria OR definite, probable or possible ALS per Awaji-Shima Criteria\n* Forced vital capacity within the last 90 days ≥ 60% of the predicted value\n* Able to consent for themselves\n* Able to read and speak English\n* Clear of any contraindications for MRI\n\nExclusion Criteria:\n\n* Individuals will be excluded if they have any condition that makes MRI unsafe or if they are unable to comply with instructions.\n* All participants will undergo a neurologic examination at enrollment. Control participants with clinically significant abnormal findings on neurological examination will be excluded from the study.",{"count":192,"type":22},90,"This is a multi-site study of ALS participants and healthy controls who will undergo brain and cervical spine MRIs and NfL blood testing at up-to 4 time points over the course of a year. The primary goal is to identify objective biomarkers of disease progression that are biologically relevant, linearly progressive, and sensitive to change.",[81,31],[196,197,198,199,200,201],"Magnetic Resonance Imaging","MRI","ALSFRS-R","ECAS","plasma neurofilament light","NfL",{"date":203,"type":43},"2026-05-12",{"date":205,"type":43},"2024-09-15",{"date":207,"type":22},"2028-08-31",{"name":209,"class":133},"University of Minnesota",{"id":211,"slug":4,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":217,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":51},"100339334","NCT03698149","ECoG BMI for Motor and Speech Control","A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control","BRAVO","Inclusion Criteria:\n\n1. Age \\> 21\n2. Limited ability to use upper limbs, based on neurological examination, due to stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis, cervical spinal cord injury, brainstem stroke, muscular dystrophy, myopathy or severe neuropathy.\n3. Disability, defined by a 4 or greater score on the Modified Rankin Scale, must be severe enough to cause loss of independence and inability to perform activities of daily living.\n4. If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms\n5. Must live within a two-hour drive of UCSF\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding\n2. Inability to understand and\u002For read English\n3. Inability to give consent\n4. Dementia, based on history, physical exam, and MMSE\n5. Active depression (BDI \\> 20) or other psychiatric illness (active general anxiety disorder, schizophrenia, bipolar disorder, obsessive-compulsive disorder (OCD), or personality disorders (e.g. multiple personality disorder, borderline personality disorder, etc.)\n6. History of suicide attempt or suicidal ideation\n7. History of substance abuse\n8. Co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer, or major organ system failure\n9. Inability to comply with study follow-up visits\n10. Any prior intracranial surgery\n11. History of seizures\n12. Immunocompromised\n13. Has an active infection\n14. Has a CSF drainage system or an active CSF leak\n15. Requires diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition\n16. Has an implanted electronic device such as a neurostimulator, cardiac pacemaker\u002Fdefibrillator or medication pump, or presence of any head or neck metallic foreign bodies\n17. Allergies or known hypersensitivity to materials in the Blackrock NeuroPort Array (i.e. silicone, titanium) or the PMT Subdural Cortical Electrode (silicone, platinum iridium, nichrome)","21 Years",{"count":106,"type":22},[62],"Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.",[31,222,69,92,223],"SCI - Spinal Cord Injury","Muscular Dystrophies","2026-04-30",{"date":226,"type":43},"2026-05-05",{"date":228,"type":43},"2018-11-09",{"date":230,"type":22},"2030-08-15",{"name":232,"class":133},"Karunesh Ganguly",{"id":234,"slug":4,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},"100627244","NCT07446114","Functional Outcomes and Control Using Synchron BCI - Canada","FOCUS-CAN","INCLUSION CRITERIA:\n\n1. Able to provide informed consent to participate in the study, in the opinion of the Investigator(s).\n2. Diagnosis of amyotrophic lateral sclerosis or motor neuron disease, with bilateral upper-limb paresis.\n3. Aged 18 years or older.\n4. Life expectancy greater than 12 months post-implantation, in the opinion of the Investigator(s).\n5. Preserved precentral gyrus assessed using CT.\n6. Suitable vascular anatomy, in the opinion of the Investigator(s), assessed using CT venography.\n7. Suitable anatomy for subcutaneous pocket creation.\n8. Able to undergo anesthesia.\n9. Willing and able to comply with investigational requirements, including clinical testing visits and training visits in the home.\n10. Caregiver(s) willing and able to facilitate study visits, including visits at the study site and in the home, and BCI use outside of study visits (e.g., device charging).\n11. Patient and Caregiver fluent in English.\n12. Suitable home environment for BCI training, including an internet connection.\n\nEXCLUSION CRITERIA:\n\n1. Unrealistic expectations regarding the potential benefits of the device, in the opinion of the Investigator(s).\n2. Active infection or unexplained fever in the 48 hours prior to informed consent.\n3. Major psychiatric disorder that may adversely impact the participant's safety or study compliance (e.g., severe depression, psychotic features, personality disorder, severe emotional lability, substance abuse), in the opinion of the Investigator(s).\n4. Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities, in the opinion of the Investigator(s).\n5. Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).\n6. Known allergy to patient-contacting materials included in the implanted device (listed in Physician Implant Manual).\n7. Contraindication to angiographic imaging or iodine contrast media.\n8. History of central venous sinus thrombosis.\n9. Recent history of new venous thromboembolic event (in the 6 months prior to implant) or recurrent history of venous thromboembolic disease.\n10. Contraindication to antithrombotic therapy, in the opinion of the Investigator(s).\n11. Participant is at substantially increased risk of infection, including immunocompromised status, recurrent or chronic infection, or poorly controlled diabetes mellitus.\n12. Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.\n13. Currently receiving or expected to require medical treatment that may be precluded by device implant, including magnetic resonance imaging, transcranial magnetic stimulation, electroconvulsive therapy, transcranial ultrasound, shortwave, microwave, and\u002For therapeutic ultrasound diathermy, or balloon angioplasty or stenting in the target vessel.\n14. Pregnant or breast feeding.\n15. Patients who are currently enrolled in any other clinical trial that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements.\n16. Patients with ALS due to SOD1 mutations on gene therapy.\n17. Any other disease or disorder that could significantly affect participation in the study, in the opinion of the Investigator(s). Examples may include corrected vision insufficient for viewing computer screens or hearing insufficient for following verbal instructions, which might impact the participant's ability to participate in BCI training and testing.",{"count":168,"type":22},[62],"Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN)",[243,31,173],"Neurologic Disorder",[31,245,246,247,173],"BCI","Brain computer interface","MND","2026-04-14",{"date":250,"type":43},"2026-04-17",{"date":252,"type":43},"2026-03-18",{"date":254,"type":22},"2027-07",{"name":183,"class":105},2,{"id":258,"slug":4,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":269,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100567206","NCT06665165","AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis","Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, PK and PD of Antisense Oligonucleotide AMX0114 Administered to Adult Participants With Amyotrophic Lateral Sclerosis","LUMINA","Inclusion Criteria:\n\n1. Ability to understand the purpose and risks of this study, willingness to comply with the study and to provide informed consent in accordance with local laws and regulations.\n2. Male or female, at least 18 years of age.\n3. Diagnosis of clinically definite or clinically probable ALS, made by a physician who is experienced with management of ALS.\n4. Time since onset of first symptom of ALS should be \\\u003C24 months prior to beginning the study. Date of ALS symptom onset is defined as the onset of weakness (in the limbs, bulbar region, or trunk).\n5. If the participant is to be treated with riluzole and\u002For edaravone before or during the trial, then treatment must be previously started and maintained at a stable regimen for at least 30 days prior to starting the study and through the end of the study.\n6. Women of childbearing potential (e.g., not post-menopausal for at least one year or surgically sterile) must agree to use an acceptable birth control method for the duration of the trial and 60 days after the last dose of Study Drug or be of non-childbearing potential.\n7. Female participants or female partners of male participants must not be pregnant or plan to become pregnant for the duration of the trial and for up to 90 days after the last dose of Study Drug.\n8. Male participants must agree to abstain from sperm donation for the duration of the trial and practice contraception with a female partner, for at least 90 days after last dose of Study Drug.\n\nExclusion Criteria:\n\n1. Presence of tracheostomy or permanent assisted ventilation.\n2. SVC less than 65%.\n3. Abnormal liver function defined as aspartate aminotransferase and\u002For alanine aminotransferase \\> 3 times the upper limit of normal (ULN) and\u002For total bilirubin \\> 1.5 times the ULN (obtained within 4 weeks of first dose) except when a result of Gilbert syndrome.\n4. Abnormal renal function defined as estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73m2.\n5. Other laboratory abnormalities, including abnormalities in platelet count, international normalized ratio, prothrombin time, and activated partial thromboplastin time.\n6. Pregnant women (confirmed by a pregnancy test within 7 days prior to first dose) or women currently breastfeeding.\n7. Current or previous clinically significant, unstable medical condition (other than ALS), that in the opinion of the Investigator could affect a participant's safety or ability to comply with the study.\n8. Significant abnormalities in physical\u002Fneurological examination, vital signs, or electrocardiogram (ECG), which in the opinion of the Investigator could affect the safety of the participant.\n9. Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that could affect the participant's ability to provide informed consent or comply with study procedures.\n10. Current or previous enrollment in another trial involving use of an investigational therapy, in most cases within 30 days after the last dose of the study drug, prior to starting this study.\n11. Current or previous treatment with small interfering ribonucleic acid, stem cell therapy, any ASO or gene therapy.\n12. Any contraindications for lumbar puncture or repeated intrathecal injection and\u002For underlying disorders that could be affected by intrathecal injections.\n13. Prior severe reaction or known hypersensitivity to any part of the Study Drug.",{"count":265,"type":22},48,[25],"This study is a placebo-controlled Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the antisense oligonucleotide (ASO) AMX0114 in adult participants with amyotrophic lateral sclerosis (ALS).",[31],[81,270,173,271,272,273],"Sporadic ALS","Antisense oligonucleotide","ASO","Calpain-2","2026-04-09",{"date":248,"type":43},{"date":277,"type":43},"2025-04-07",{"date":279,"type":22},"2027-10",{"name":281,"class":105},"Amylyx Pharmaceuticals Inc.",14,{"id":284,"slug":4,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":297,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":303,"locationsCount":4},"100485520","NCT05602142","Study of [11C]CPPC as a Clinical PET Radioligand Biomarker of Microglial Activation in ALS","A Phase 1\u002F2 Study of [11C]CPPC as a Clinical PET Radioligand Biomarker of Microglial Activation in ALS","Inclusion Criteria\n\n1. Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) \\[per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling\\] and comply with the study procedures.\n2. Men and women at least 18 years old.\n3. Male patients, who have not had a vasectomy and a confirmed zero sperm count, must agree for the duration of the study to:\n\n   * use a condom during sexual intercourse with female partners who are of reproductive potential AND to have female partners use an additional effective means of contraception (e.g., diaphragm plus spermicide, or oral contraceptives) OR\n   * male patient must agree to abstain from sexual intercourse during the study\n4. Women must have a negative serum pregnancy test and practice an acceptable method of contraception or be of non-childbearing potential (post-menopausal for at least 2 years or who have undergone hysterectomy, oophorectomy or surgical sterilization). Women must not be breastfeeding.\n5. Geographic accessibility to the study center and the ability to travel to the clinic for study visits.\n6. Presence of a willing and able caregiver.\n7. Diagnosis of ALS based on examination by the site PI, meeting El Escorial criteria for possible, laboratory-supported probable, probable or definite ALS or be a person without a diagnosis of ALS disorder.\n8. Vital capacity ≥ 50% of predicted normal for age, height and gender measured in the seated position and the ability to lie supine for a period of 1 hour.\n9. Agrees to the visit schedule as outlined in the informed consent.\n10. Pre-study labs within normal range, or if abnormal, deemed not clinically significant by the site investigator.\n\nExclusion Criteria:\n\n1. Weakness due to causes other than ALS.\n2. Receipt of any investigational drug, device or biologic within 10 days of administration of study compound.\n3. Use of anti-inflammatory medications, immunosuppressants, or benzodiazepines within 7 days of administration of study compound.\n4. Any concomitant medical disease or condition limiting the safety to participate including, but not limited to:\n\n   1. Coagulopathy\n   2. Active infection\n5. Any condition that the site PI feels may interfere with participation in the study.\n6. Inability to provide informed consent as determined by the site PI.\n7. Known clinical evidence of frontotemporal dementia.\n8. Inadequate family or caregiver support as determined by the site PI.\n9. Presence of any of the following conditions:\n\n   1. Current drug abuse or alcoholism\n   2. Unstable medical conditions\n   3. Unstable psychiatric illness including psychosis and untreated major depression within 90 days of screening",{"count":290,"type":22},20,[25,292],"PHASE2","1. Establish the safety and tolerability of the 5-cyano-N-(4-(4-\\[11C\\]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide (\\[11C\\]CPPC) PET radioligand in ALS patients and controls\n2. Examine whether \\[11C\\]CPPC PET uptake is elevated in brains of ALS patients and whether there is a correlation with clinical phenotype.\n3. Correlate \\[11C\\]CPPC PET imaging with other ALS outcome measures and biofluid biomarkers\n4. Examine longitudinal changes in \\[11C\\]CPPC PET imaging during disease course.",[31],[296],"Biomarkers","NOT_YET_RECRUITING",{"date":299,"type":43},"2026-04-13",{"date":301,"type":22},"2026-08",{"date":254,"type":22},{"name":304,"class":133},"Johns Hopkins University",{"id":306,"slug":4,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":114,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":106},"100550944","NCT06453668","A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients","A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)","AURORA","Key Inclusion Criteria:\n\n* Male or female patients ≥ 18 to 80 years of age.\n* Diagnosis of ALS by revised El Escorial Criteria, at study entry within 24 months of first symptoms.\n* Patients on existing ALS treatment must have been on a stable dose for 28 days.\n\nKey Exclusion Criteria:\n\n* Patient with severe systemic infections, current or within the two weeks prior to randomization.\n* Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.\n* Use of other investigational products or treatment in another investigational drug study within 30 days of screening\n* Pregnant or nursing (lactating) women.",{"count":265,"type":22},[25],"The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.",[31],[81,317],"Neuroinflammatory","2026-03-25",{"date":320,"type":43},"2026-03-31",{"date":322,"type":43},"2024-04-16",{"date":324,"type":22},"2029-11",{"name":326,"class":105},"ITB-Med LLC",{"id":328,"slug":4,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":297,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":4},"100555550","NCT06513546","A Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of PLL001 in ALS Patients","A Multi-centre, Phase 1\u002F2, Randomised, Double-blind, Placebo Controlled Study With an Optional Open-label Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics of PLL001 for the Treatment of ALS","Inclusion Criteria:\n\n1. Males and females ≥18 years of age at the time of informed consent.\n2. Diagnosed within the previous 1 year with laboratory-supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria.\n3. Must have familial or sporadic ALS.\n4. First ALS symptoms occurred no more than two (2) years prior to screening visit ALS disease duration from diagnosis no longer than 12 months at the Screening visit.\n5. If treated with riluzole, edaravone or any other approved ALS medication, treated with a stable dose for at least 4 weeks prior to Day 1.\n6. If documented, patient with an ALSFRS-R score progression between onset of the disease and Screening of \\> 0.3 per month, confirmed with an ALSFRS-R score progression of ≥ 1 point during a 12 week prior to randomisation.\n7. Has a score of at least 26 overall, including a score of at least 3 on item #3 and at least 2 on each of the 12 ALSFRS-R individual component items at Screening and at least 2 on each of the 12 ALSFRS-R individual component items at randomisation.\n8. Seated slow vital capacity (SVC) ≥ 50% of predicted value for gender, height, and age at screening.\n9. Must be willing and able to comply with the requirements of the protocol and must be available to complete the study.\n10. Must provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Has dementia or significant neurological, psychiatric, systemic, or organic disease, uncontrolled or that may interfere with the conduct of the trial or its results.\n2. Pregnant or nursing females.\n3. History of drug\u002Fchemical\u002Fsubstance\u002Falcohol abuse within the past 2 years prior to Screening, including cannabinoid therapies.\n4. Significant symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within the past 2 weeks prior to study medication administration (at the discretion of the Investigator).\n5. Mechanical ventilation via tracheostomy or dependence on non-invasive ventilation, (\\> 16 hours \u002F day). (Lesser intermittent use of non-invasive ventilation eg, continuous positive airway pressure, non-invasive bi-level positive airway pressure or non-invasive volume ventilation is not an exclusion).\n6. Patients positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg).\n7. Sexually active females of childbearing potential and male subjects who are not practicing at least one method of hormonal or mechanical birth control with their partner during the study and for 90 days after the last dose of the study medication. Males and females who are not heterosexually active or who practice true abstinence are exempt from contraceptive requirements.\n8. Experimental agent within 30 days or 5 half-lives, whichever is longer, prior to study drug administration (Part 1 only).\n9. Any other condition which, in the opinion of the Investigator, precludes participation in the study.\n10. Dependents of the Sponsor or Investigator.\n11. Known allergy to the study drug and\u002For its constituents.","75 Years",{"count":335,"type":22},153,[25,292],"FIH, Phase 1\u002F2, multi-centre, randomised, double-blind, placebo controlled study with an optional open-label dosing extension to assess the safety, tolerability, efficacy, and Pharmacodynamics (PD) of single or multiple (up to 48 weeks QD) subcutaneous (SC) doses of PLL001 compared to placebo in subjects diagnosed with ALS.",[81,31],"2026-03-17",{"date":341,"type":43},"2026-03-19",{"date":343,"type":22},"2026-04-08",{"date":345,"type":22},"2027-06-15",{"name":347,"class":105},"PLL TX AUSTRALIA PTY LTD",{"id":349,"slug":4,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":354,"phases":4,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":357,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":361,"locationsCount":363},"100573245","NCT06743776","Scalable Expanded Access With Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS","SEANOBI-ALS","Inclusion Criteria\n\n1. ALS by \"Gold Coast\" diagnostic criteria\n2. Age \\> 18 years\n3. Either I) Ineligibility for interventional ALS clinical research participation due to at least one of the following standard exclusion criteria:\n\n   1. Time since onset of weakness due to ALS \\> 36 months\n   2. Vital Capacity less than 50% of predicted capacity for age, height, and sex measured (by Slow Vital Capacity (SVC) or Forced Vital Capacity (FVC))\n   3. Cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.\n   4. Geographic inaccessibility from nearest actively enrolling research trial site for a trial the patient would otherwise qualify for, defined as either \\>200 miles or, in the opinion of the investigator, a distance that would make trial participation infeasible for the particular patient, due to significant disease progression or special logistical circumstances. OR II) Former COMBAT-ALS participant or current participant who has completed dosing in the OLE and may be consented at the final OLE follow-up visit.\n4. Female patients of childbearing potential must use one or more effective methods of contraception throughout the entire EAP and for 30 days after discontinuing MN-166.\n5. Male patients agree to practice contraception (e.g., condom use and contraception by female partner) unless partner is post-menopausal or unable to conceive throughout the entire EAP and for 30 days after discontinuing MN-166.\n\nExclusion Criteria\n\n1. Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to treating physician's judgment (e.g., psychiatric, cardiovascular instability, systemic infection, untreated thyroid dysfunction, or clinically significant laboratory abnormality or ECG changes).\n2. Clinically significant lab abnormalities in the opinion of the treating physician, including, but not limited to: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin greater than 3 times the upper limit of normal (ULN), white blood cell count \\\u003C2500\u002Fmm3, platelet count \\\u003C75,000\u002Fmm3\n3. Active drug or alcohol abuse\n4. Female patient is lactating, pregnant, or planning pregnancy at Clinical Screening or Lab Screening\n5. Concomitant use of another investigational medical product for treatment of ALS. Any such investigational medical product must be discontinued for a minimum of 5 half-lives prior to the first dose of MN-166.\n6. Concomitant use of prohibited medications. Refer to Program Procedure Manual Appendix 3 for a list of prohibited medications.\n7. Past participant in COMBAT-ALS clinical trial who did not complete the study.\n8. Past participant in an ALS research trial who did not complete the study without cause.","EXPANDED_ACCESS","The purpose of this Expanded Access Program is to provide MN-166 (ibudilast) to ALS patients who are not eligible for an enrolling ALS clinical trial. This Expanded Access Program will assess if MN-166 can help people with ALS in slowing down the progression of the disease.",[31],"AVAILABLE","2026-03-10",{"date":360,"type":43},"2026-03-12",{"name":362,"class":133},"Mayo Clinic",15,{"id":365,"slug":4,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":17,"minAge":370,"maxAge":114,"enrollmentInfo":371,"targetDuration":4,"studyType":23,"phases":373,"briefSummary":374,"conditions":375,"keywords":382,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":51},"100628315","NCT07460037","Chinese-Specific Speech Imagery Coding Using High-Density ECoG","Investigation of Chinese-Specific Speech Imagery Encoding and Decoding Using High-Density Electrocorticography","Inclusion Criteria:\n\n* Age between 20 and 80 years.\n* Ability and willingness to provide informed consent and comply with study procedures.\n* No severe preoperative emotional or consciousness disorders that would preclude participation in experimental tasks.\n* For patients undergoing intraoperative temporary high-density ECoG coverage: Patients with cerebral eloquent-area gliomas or refractory epilepsy undergoing awake craniotomy as part of standard clinical management.\n* For patients undergoing intraoperative temporary high-density ECoG coverage: Lesions involving or adjacent to eloquent brain areas including language, motor, or memory-related regions.\n* For patients undergoing intraoperative temporary high-density ECoG coverage: Mild mass effect without severe intracranial hypertension.\n* For patients undergoing intraoperative temporary high-density ECoG coverage: Preoperative language function largely preserved, with naming, reading, and language comprehension ≥80% of normal performance.\n* For patients undergoing permanent high-density ECoG implantation: Severe speech or language dysfunction caused by stroke, brain tumors, amyotrophic lateral sclerosis (ALS), or locked-in syndrome.\n* For patients undergoing permanent high-density ECoG implantation: No substantial improvement after 3-6 months of adequate rehabilitation and disease duration \\>12 months.\n* For patients undergoing permanent high-density ECoG implantation: Structural integrity of speech imagery-related cortices (ventral central lobule, supramarginal gyrus, superior temporal gyrus, middle temporal gyrus, middle frontal gyrus, and inferior frontal gyrus).\n* For patients undergoing permanent high-density ECoG implantation: Diagnosis of severe dysarthria or severe motor aphasia, with spontaneous speech score \\\u003C5\u002F20 on the Aphasia Battery of Chinese (ABC) and auditory comprehension ≥80% of normal levels.\n\nExclusion Criteria:\n\n* Significant mass effect with severe intracranial hypertension precluding awake craniotomy or electrode implantation.\n* Severe neurological dysfunction that would prevent participation in study procedures (except for speech or language impairment in the permanent implantation cohort).\n* Contraindications to MRI scanning or awake craniotomy, including incompatible implanted medical devices, severe claustrophobia, or obstructive sleep apnea syndrome.\n* Severe psychiatric disorders or cognitive impairment preventing participation in treatment or follow-up assessments (Mini-Mental State Examination score \\\u003C24).\n* Severe systemic medical comorbidities.\n* Pregnancy or lactation.\n* Refusal or inability to provide informed consent.","20 Years",{"count":372,"type":22},50,[62],"The goal of this study is to investigate whether high-density electrocorticography (ECoG) signals recorded from the surface of the brain can be used to decode neural representations of Mandarin Chinese speech features, including lexical tone, without requiring overt speech movements. The study focuses on the development and evaluation of decoding algorithms based on neural activity recorded during clinically indicated neurosurgical procedures.\n\nThe main questions it aims to answer are:\n\nCan high-density ECoG signals be decoded to reconstruct neural representations of Mandarin Chinese speech features, particularly lexical tone?\n\nCan neural activity recorded during silent auditory speech imagery be decoded to reconstruct tone-specific speech representations without actual articulation?\n\nThe study includes two groups of adult patients with neurological conditions who require cortical electrode placement as part of clinically indicated care:\n\nA intraoperative high-density ECoG temporary coverage group, enrolling approximately 50 patients with functional-area glioma or drug-resistant epilepsy who undergo awake neurosurgery with temporary high-density ECoG coverage for clinical functional mapping.\n\nA permanent high-density ECoG implantation group, enrolling approximately 10 patients with severe speech or language impairment caused by neurological conditions such as stroke, brain tumors, amyotrophic lateral sclerosis (ALS), or locked-in syndrome, who receive permanent high-density cortical electrode implantation for long-term monitoring.\n\nParticipants will:\n\nComplete preoperative clinical assessments as part of standard medical care, including brain imaging, language function evaluation, and routine neurological assessments\n\nUndergo clinically indicated awake neurosurgical procedures during which high-density ECoG electrodes are placed on the cortical surface for clinical functional localization\n\nPerform language-related tasks, such as listening to speech, imagining speech, and limited spoken responses, while brain electrical activity is recorded for approximately 20-30 minutes during surgery, without altering standard surgical procedures\n\nFor participants in the permanent implantation group, participate in long-term follow-up visits approximately every 2 weeks or monthly for up to 12 months after surgery, including evaluation of signal quality and research-related analysis and optimization of decoding algorithms\n\nAll surgical procedures involving temporary or permanent electrode placement are performed for clinical indications and have been approved through institutional ethical and scientific review. Participation in this study does not alter standard clinical care for the temporary recording group and does not require additional clinical procedures beyond routine treatment.\n\nThis research aims to support the long-term development of silent brain-to-speech communication technologies for individuals with severe speech or motor impairments and to improve understanding of how frontal, parietal, and temporal brain regions represent imagined speech in tonal languages such as Mandarin Chinese.",[376,377,31,378,69,379,380,381],"Aphasia","Dysarthria","Speech and Language Disorder","Brain Tumor Adult","Epilepsies","locked-in Syndrome",[383,384,385,386,387],"speech imagery","speech production","Chinese Mandarin","neural encoding","speech decoding","2026-03-09",{"date":358,"type":43},{"date":391,"type":22},"2026-03-15",{"date":393,"type":22},"2028-12-31",{"name":395,"class":133},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":397,"slug":4,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":139,"enrollmentInfo":402,"targetDuration":404,"studyType":143,"phases":4,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":297,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":416,"leadSponsor":417,"locationsCount":51},"100619185","NCT07341334","Digital Speech Markers for Monitoring ALS in Spanish Speakers","Developing Digital Speech Biomarkers of Bulbar Disease Decline in Spanish-Speaking Persons With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n* diagnosis of definite ALS\n* monolingual or first language Spanish speaker\n* literate in Spanish\n* ALS Functional Rating Scale speech score of ≧2\n\nExclusion Criteria:\n\n* no diagnosis of concomitant respiratory disease such as COPD, emphysema, or current TOB use.",{"count":403,"type":22},35,"4 Years","The goal of this observational study is to learn how speech and breathing change over time in Spanish-speaking individuals with amyotrophic lateral sclerosis (ALS) compared to age- and gender-matched individuals without ALS.\n\nThe main questions it aims to answer are:\n\nCan speech and breathing measures collected through a smartphone application serve as reliable digital biomarkers to track bulbar disease decline in Spanish-speaking people with ALS?\n\nHow do these measures differ between individuals with ALS and those without ALS?\n\nResearchers will compare Spanish-speaking participants with ALS to age- and gender-matched healthy controls to see if specific speech and breathing features can identify or predict bulbar decline.\n\nParticipants will:\n\nUse a Spanish-language smartphone application to record speech and breathing tasks over time.\n\nComplete assessments of speech, breathing, and functional abilities (e.g., ALS Functional Rating Scale).\n\nProvide data that will be compared to caregiver reports and clinical outcomes to validate new digital biomarkers.",[81,407,31],"Lou Gehrig's Disease",[409,410,411,31],"speech biomarkers","amyotrophic lateral sclerosis","Lou Gehrig's disease","2026-02-23",{"date":414,"type":43},"2026-02-25",{"date":179,"type":22},{"date":181,"type":22},{"name":418,"class":133},"Nova Southeastern University",{"id":420,"slug":4,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":427,"studyType":143,"phases":4,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":297,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":4},"100623727","NCT07400393","Healey ALS MyMatch Common Screening Protocol","Healey ALS MyMatch Common Screening Protocol (MCSP) for Determining Preliminary Eligibility for ALS MyMatch Early Phase Clinical Trials","MCSP","Inclusion Criteria:\n\n1. Ability to provide written informed consent.\n2. Adults \\> 18 years of age.\n3. Diagnosis of symptomatic ALS that meets either the revised El Escorial Criteria.(clinically possible, probable, probable lab-supported, or definite) or the Gold Coast Criteria.\n4. Available or pending clinically obtained CLIA ALS genetic panel report.\n5. Time since onset of weakness due to ALS ≤ 24 months at the time of MCSP screening.\n6. Slow VC ≥ 65% of predicted capacity value for gender, height and age at screening.\n7. Clinically unremarkable Complete Blood Counts as per SI's discretion, including but not limited to Hemoglobin ≥ 9 g\u002FdL.\n8. Ability and willingness to complete all study procedures per SI's assessment.\n9. Negative pregnancy test at screening for women of child-bearing potential (WOCB), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months).\n\nExclusion Criteria:\n\n1. Clinically significant unstable medical or surgical condition that would pose a risk to the participant's trial procedural participation or interfere with data collection, per SI's assessment.\n2. Presence of cognitive or mental health disorders impairing ability to provide informed consent for the study per SI assessment.\n3. Active cancer or history of cancer, unless it was successfully treated for durable remission or cure more than 3 years ago. (Note that basal cell carcinoma, squamous cell carcinoma in situ, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies that have been curatively excised at any time previously and with no evidence of disease recurrence for at least 3 years are not exclusionary.)\n4. Prior solid organ transplantation.\n5. Use of investigational treatments for ALS (off-label use or active participation in a clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the MCSP Screening Visit. (Please refer to the Manual of Procedures (MOP) for current list of experimental therapies)\n6. Screening 12-lead ECG showing QT interval corrected for rate (QTcF) \\> 470 msec for women and \\> 450 msec for men, absence of second degree or higher AV block or other clinically significant cardiac arrythmias.\n7. Clinically significant abnormalities in the Comprehensive Metabolic Panel per SI's assessment, including but not limited to:\n\n   1. Serum alanine aminotransferase or aspartate aminotransferase \\> 3 times the upper limit of normal, or serum bilirubin \\> 1.5 × upper limit of normal\n   2. Estimated GFR (eGFR) of \\\u003C 30 mL\u002Fmin\u002F1.73m2\n8. Other clinically significant electrolyte and metabolic abnormalities\n9. If female, breastfeeding, pregnant, or of child-bearing potential and unwilling to use effective contraception for duration of the trial and after discontinuing treatment as outlined in the ALS MyMatch trial protocol.\n10. Clinically significant unstable medical conditions (other than ALS) that would pose a risk to the participant, per SI's assessment (e.g., cardiovascular instability, systemic infection,), or clinically significant laboratory abnormality or ECG changes.\n11. Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational).\n12. Participants who require Permanent assisted ventilation (PAV). PAV defined as more than 22 hours per day of noninvasive or invasive mechanical ventilation for more than seven consecutive days. The date of onset of PAV is the first day of the seven days.",{"count":60,"type":22},"45 Days","The goal of the Healey ALS MyMatch Common Screening Protocol (MCSP), an observational study, is to identify individuals with ALS who may be eligible to be matched to a currently enrolling ALS MyMatch trial. Participants will complete a MCSP Screening Visit and undergo clinical assessments, laboratory testing, and biomarker analyses to determine preliminary trial eligibility. The study also characterizes clinical, genetic, and biofluid biomarker profiles, assesses the prevalence of ALS-associated gene variants, and banks blood samples for future ALS and biomarker research. MCSP enables simultaneous screening for multiple trial-specific biomarkers and uses a targeted medical history form to optimize matching of participants to appropriate MyMatch trials.",[31,172,174],[31,81,431,432,433,424,434,435,436,437,438,439,440,441,442],"MyMatch","ALS MyMatch","MyMatch Program","MyMatch Common Screening Protocol","Early Phase","Biomarker","Phase I","Phase II","Healey","NCRI","ALS Trials","MGB","2026-02-06",{"date":445,"type":43},"2026-02-10",{"date":447,"type":22},"2026-03-16",{"date":449,"type":22},"2029-03-16",{"name":159,"class":133},{"id":452,"slug":4,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":333,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":297,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":4},"100623452","NCT07396818","Kamlanoflast In Amyotrophic Lateral Sclerosis","A Trial of Kamlanoflast In Patients With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n1. Diagnosis of definite, probable, laboratory-supported probable, or possible ALS by revised El Escorial research criteria.\n2. Ages 18 to 75 years.\n3. Onset of weakness within three years of study enrollment.\n4. ALS with progression, characterized either by:\n\ni. a reduction of 0.5 points per month or greater on the ALS Functional Rating Scale-Revised (ALSFRS-R), which will be calculated based on (most recent ALSFRS-R at least 12 weeks from screening - ALSFRS-R at screening)\u002Ftime interval; or ii. a calculated progression rate: (48 - ALSFRS-R at \"time of diagnosis\") \u002F duration from onset to diagnosis (month) that is 0.5 points per month or greater.\n\ne) Plasma NfL levels ≥ 2 times the upper limit of the age-specific reference values for normal at the measuring laboratory at screening.\n\nf) Capable of providing informed consent. g) Capable and willing to follow study protocol. h) Ability to swallow pills and liquids at the time of the screening visit and, in the investigator's opinion have the ability to swallow for the duration of the study OR can be fed via a Gastrostomy (G) tube or Percutaneous Endoscopic capacity (PEG) tube.\n\ni) Slow vital capacity (SVC) \\> 65% of predicted value for gender, height, and age (participants perform SVC for three trials and the best SVC will be used).\n\nj) Females of childbearing potential must agree to abstain from sex or use adequate method of contraception for the duration of the study period and for 28 days after the last dose of study drug.\n\nk) Males must agree to abstain from sex or use adequate method of contraception for the duration of the study period and for 28 days after the last dose of study drug.\n\nl) If an approved therapy for ALS is used during the study, a steady dose must be used as follows: i. Participants who do not currently receive riluzole and do not plan to receive riluzole during the study period. Participants receiving riluzole are on a stable dose for at least 4 weeks before enrollment. Participants receiving riluzole are expected to remain on the same dose throughout the duration of the study.\n\nii. Participants who do not currently receive edaravone and do not plan to receive edaravone during the study period. Participants receiving edaravone must have completed at least 1 cycle of treatment before enrollment and are expected to continue edaravone treatment throughout the duration of the study.\n\nExclusion Criteria:\n\n1. Inability to follow the study protocol, based on the investigator's assessment.\n2. Pregnant or nursing women.\n3. Recently（within 28 days）received other experimental treatments.\n4. Presence of any active infections or inflammatory diseases at the time of enrollment that may confound the assessment of levels of inflammatory markers.\n5. Taking any medication or supplements with anti-inflammatory effects, including but not limited to prednisone, colchicine, or curcumin.\n6. Taking Qalsody (tofersen).\n7. Taking any medications containing nucleotide reverse transcriptase inhibitors (NRTIs), including but not limited to Abacavir, Emtricitabine, Lamivudine, or Zidovudine; trade names Atripla, Biktarvy, Cimduo, Combivir, Complera, Delstrigo, Descovy, Dovato, Emtriva, Epivir, Epzicom, Genvoya, Odefsey, Retrovir, Stribild, Symfi, Symtuza, Triumeq, Trizivir, Truvada, Ziagen.\n8. Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to investigator's judgment (e.g., cardiovascular instability, systemic infection), or clinically significant laboratory abnormality.\n9. Clinically significant abnormal liver or kidney function at baseline (pre-dose). The following values \\[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m2\\] are exclusionary regardless of clinical symptoms.\n10. Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent, in the investigator's opinion.\n11. Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.\n12. Non-invasive ventilation, tracheostomy, oxygen supplementation for primary pulmonary pathology.\n13. Current \u002F anticipated need of diaphragm pacing system (DPS).\n14. History of prior AAV gene therapy for any indication;\n15. Presence of any clinically relevant diseases that, in the research team's opinion, would prevent the subject from completing the study, including but not limited to severe cognitive dysfunction or medical conditions other than ALS that affect physical function or life expectancy.\n16. Plan to move away from the study site within the next 6 months.",{"count":458,"type":22},40,[25,292],"This is a study of Kamlanoflast in patients with ALS. Kamlanoflast is orally administered over 24 weeks. Its effects on inflammatory and functional parameters will be studied. Information on safety and tolerability will be collected.",[172,31,462,463,464],"Neuro-Degenerative Disease","Neuro-Degenerative Diseases","Motor Neuron Disease (MND)","2026-02-02",{"date":467,"type":43},"2026-02-09",{"date":469,"type":22},"2026-02",{"date":471,"type":22},"2027-01",{"name":473,"class":105},"Inflammasome Therapeutics",{"id":475,"slug":4,"hasResults":11,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":493,"locationsCount":51},"100538137","NCT06286917","Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency","InNIVALS","Inclusion Criteria:\n\n* ALS diagnosed by a neurology and\n* chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS\n\nExclusion Criteria:\n\n* impaired cognition to give informed consent to participation\n* contraindication to NIV therapy\n* another severe disease with a prognosis of less than one year\n* ventilation via an artificial airway, tracheostomy",{"count":481,"type":22},120,[62],"This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are.",[485,31,486],"Ventilation Therapy","Chronic Respiratory Failure","2026-01-23",{"date":489,"type":43},"2026-01-27",{"date":491,"type":43},"2024-03-05",{"date":181,"type":22},{"name":494,"class":133},"Tampere University",{"id":496,"slug":4,"hasResults":11,"nctId":497,"briefTitle":498,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":500,"enrollmentInfo":501,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":503,"conditions":504,"keywords":505,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":522,"locationsCount":51},"100352173","NCT03865420","Amyotrophic Lateral Sclerosis (ALS) Families Project","Inclusion Criteria:\n\n* Men or women of any race or ethnicity aged 18 or older\n* No symptoms of ALS or fronto-temporal dementia at enrollment\n* Scenario 1: has already had genetic testing that identified an ALS-spectrum gene mutation.\n* Scenario 2: has a first degree relative who was\u002Fis an obligate carrier of a familial ALS-spectrum gene mutation.\n* Scenario 3: has a first degree relative who has\u002Fhad an ALS-spectrum diagnosis who had a confirmed ALS-spectrum gene mutation or comes from a family with a high burden of ALS-spectrum diagnoses and a known ALS-spectrum gene mutation.\n* Scenario 4: is deemed to be at high risk for carrying an ALS-spectrum gene mutation as judged by a review of the family structure and genetic information by the study team.\n* Willing to undergo genetic analysis, with option of whether or not to learn results\n* Willing to travel to Columbia University Irving Medical Center (CUIMC) every 6-24 months for study procedures\n* Capable of providing informed consent and following study procedures, or has a legally authorized representative who is able to consent for the subject.\n\nExclusion Criteria for participation in biosample portion of the study:\n\n* Known HIV\n* Known hepatitis B\n* Known hepatitis C","105 Years",{"count":502,"type":22},300,"This program provides family members of individuals with familial ALS the opportunity to contribute to research focused on learning more about why motor neuron degeneration begins and how or why it progresses. This study provides genetic counseling and testing to help participants understand and manage their risk and determine if they want to learn their genetic status. This study will follow unaffected ALS gene mutation carriers on an annual basis to gather essential information that will ultimately help researchers develop novel therapies for the prevention and treatment of ALS.",[31],[506,507,508,509,510,511,512,513,514,515],"Pre-symptomatic","Familial","FALS","Genetic testing","C9orf72","SOD1","TARDBP","FUS","VCP","PFN1","2026-01-05",{"date":518,"type":43},"2026-01-07",{"date":520,"type":43},"2018-09-11",{"date":471,"type":22},{"name":523,"class":133},"Columbia University",{"id":525,"slug":4,"hasResults":11,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":139,"enrollmentInfo":530,"targetDuration":4,"studyType":23,"phases":532,"briefSummary":533,"conditions":534,"keywords":537,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":51},"100509473","NCT05913882","Combined Respiratory Training in Persons With ALS","Combined Respiratory Training to Improve Pulmonary and Cough Function in Persons With ALS","Inclusion Criteria:\n\n1. A diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria.\n2. Disease duration from symptom onset of ≤ 2 years,\n3. Lung volume recruitment and expiratory muscle strength training naïve,\n4. Reduced peak cough flow (% predicted for age and gender).\n\nExclusion Criteria:\n\n1. History of stroke, head and neck cancer or other concomitant disorder that might contribute to dysphagia or respiratory impairment.\n2. Use of prescription cough assist or non-invasive volume ventilation devices.\n3. Enrollment in another research investigation that might impact cough or respiratory function.\n4. Diagnosis of frontotemporal dementia or advanced cognitive impairment.\n5. Tracheostomy placement\u002FUse of invasive mechanical ventilation.\n6. Contraindications for respiratory training (i.e., history of pneumothorax, severe chronic obstructive pulmonary disease).",{"count":531,"type":22},34,[62],"The goal of this interventional trial is to learn about lung volume recruitment (LVR) and expiratory muscle strength training (EMST) in a total of up to 39 patients diagnosed with ALS. The following aims will be addressed:\n\n1. Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS.\n2. Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment.\n3. Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.",[31,535,536],"Respiratory Insufficiency","Dysphagia",[538,539,540,541],"Breathing","Swallowing","Exercise","Bulbar","2025-12-16",{"date":544,"type":43},"2025-12-23",{"date":546,"type":43},"2023-08-22",{"date":548,"type":22},"2026-09-30",{"name":418,"class":133},{"id":551,"slug":4,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":558,"briefSummary":559,"conditions":560,"keywords":561,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":51},"100607853","NCT07193953","Intravenous Immunoglobulin (IVIG) and Blood-Brain Barrier Disruption in Amyotrophic Lateral Sclerosis (ALS)","Targeting Neuroinflammation With Enhanced Delivery of Intravenous Immunoglobulin to the Motor Cortex Using Next Generation Dome Helmet Focused Ultrasound in Amyotrophic Lateral Sclerosis: A Phase I, Open Label Trial","ALSFUS003","Inclusion Criteria:\n\n1. Diagnosed with ALS as per the Gold Coast Criteria;\n2. Aged 18 years or older;\n3. Capable of providing informed consent and complying with study procedures;\n4. If taking Riluzole, on a stable dose for at least 4 weeks prior to Baseline;\n5. If taking Edaravone, on a stable dose of one completed cycle prior to Baseline;\n6. Respiratory Function Criterion:\n\n   * Able to lie supine without BiPAP or breathing discomfort; OR\n   * Forced vital capacity or slow vital capacity ≥50% of the predicted value for sex, height and age, if available\n7. Able to communicate sensations during the Dome FUS procedure.\n8. Qualified fit for the anesthesia by an anesthesiologist, ASA I-III.\n\nExclusion Criteria:\n\n1. MRI findings:\n\n   1. Active infection\u002Finflammation\n   2. Acute or chronic hemorrhages, specifically \\> 4 lobar microbleeds, and no siderosis or macrohemorrhages\n   3. Tumor\u002Fspace occupying lesion causing significant mass effect\n   4. Meningeal enhancement\n   5. Intracranial hypotension\n2. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp\n3. Clips or other metallic implanted objects in the skull or the brain, except shunts\n4. Significant cardiac disease or unstable hemodynamic status including:\n\n   1. Documented myocardial infarction within six months of screening\n   2. Unstable angina on medication\n   3. Unstable or worsening congestive heart failure\n   4. Left ventricular ejection fraction below the lower limit of normal\n   5. History of a hemodynamically unstable cardiac arrhythmia\n   6. Cardiac pacemaker\n   7. Severe hypertension (diastolic BP \\> 100 on medication)\n   8. Patient has right-to-left, bidirectional, or transient right-to-left cardiac shunts\n   9. QT prolongation observed on screening ECG (QTc \\> 450 for men and \\> 470 for women)\n5. Uncontrolled hypertension (systolic \\> 150 and diastolic BP \\> 100 on medication)\n6. Patients should not take medications known to increase risk of hemorrhage (e.g., aspirin or class I and III anticoagulants) for at least 7 days prior to treatment or lumbar puncture; patients should not take Avastin for 30 days prior to treatment\n7. History of a bleeding disorder, coagulopathy or a history of spontaneous hemorrhage or use of anticoagulants, specifically recent thrombosis or stroke in past 3 months; abnormal coagulation profile (PLT \\\u003C 100,00\u002Fμl), PT (\\> 14 sec) or PTT (\\> 36 sec), and INR \\> 1.3\n8. No more than 1 non-strategic lacune \\<1.5 cm\n9. Known cerebral or systemic vasculopathy\n10. Significant depression and at potential risk of suicide\n11. Known sensitivity\u002Fallergy to gadolinium (an alternative product may be used) and DEFINITY®.\n12. Any contraindications to MRI scanning, including:\n\n    1. Large participants not fitting comfortably into the scanner\n    2. Difficulty lying supine and still for up to 3 hours in the MRI unit or claustrophobia\n13. Any contraindication to lumbar puncture for collection of cerebral spinal fluid, including:\n\n    a. Intracranial hypotension\n14. Untreated, uncontrolled sleep apnea\n15. Impaired renal function with estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73m2 or on dialysis.\n16. IVIg use in the previous 6 months.\n17. Live viral vaccination within the 30 days before study entry\n18. Currently, or in the last 3 months participated in a clinical trial delivering an investigational product or non-approved use of a drug or device or in any other type of medical research.\n19. Respiratory: chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area, patients with a history of drug allergies, uncontrolled asthma or hay fever, and multiple allergies where the benefit\u002Frisk of administering DEFINITY® is considered unfavorable by the study physicians in relation to the product monograph for DEFINITY®.\n20. Motor cortex atrophy deemed severe enough to limit targeting\n21. Previous major allergic or anaphylactic reaction to IVIg\n22. Known IgA deficiency with anti-IgA.\n23. Known frontotemporal dementia;\n24. Definitely or possibly pregnant (if applicable);\n25. Known auto-immune condition with or without neurological manifestations (e.g., multiple sclerosis (MS), systemic lupus erythematous (SLE), Rheumatoid arthritis).\n26. Current, planned or previous use of oral, intramuscular or intravenous steroid drugs (such as prednisone, prednisolone, dexamethasone, triamcinolone, methylprednisolone, oxandrolone, and others), immunosuppressant drugs (azathioprine, mycophenolate, tacrolimus, sirolimus, cyclophosphamide, and others) or NSAIDs (ibuprofen, naproxen, celecoxib, and others) in the past 30 days;\n27. Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrollment",{"count":116,"type":22},[25],"The goal of this study is to evaluate the safety and feasibility of IVIg administration in conjunction with primary motor cortex BBB opening using the Next Generation Dome Helmet (NGDH) FUS in adult participants with ALS.",[81,31],[31,562,563,564,173],"Focused Ultrasound","Blood Brain Barrier Opening","Intravenous Immunoglobulin","2025-09-18",{"date":567,"type":43},"2025-09-26",{"date":569,"type":43},"2025-04-15",{"date":571,"type":22},"2027-05-30",{"name":573,"class":133},"Sunnybrook Health Sciences Centre",{"id":575,"slug":4,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":23,"phases":582,"briefSummary":583,"conditions":584,"keywords":592,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":51},"100545064","NCT06377033","Using the EHR to Advance Genomic Medicine Across a Diverse Health System","Using Behavioral Economics and Implementation Science to Advance the Use of Genomic Medicine Utilizing an EHR Infrastructure Across a Diverse Health System","Inclusion Criteria:\n\n* 18 years of age or older\n* diagnosed with one of the study conditions\n\nExclusion Criteria:\n\n* Under 18 years of age\n* not diagnosed with one of the study conditions",{"count":581,"type":22},1000,[62],"Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place.\n\nInnovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and\u002For patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management.",[585,586,587,31,588,589,85,84,590,591],"Genetic Predisposition","Paraganglioma","Pheochromocytoma","Parkinson Disease","Polyneuropathies","Cardiomyopathy Non-ischemic","Thoracic Aortic Aneurysm",[509,593,594],"Genomic medicine","Electronic health record","2025-07-16",{"date":597,"type":43},"2025-07-20",{"date":599,"type":43},"2024-06-10",{"date":601,"type":22},"2027-06-30",{"name":603,"class":133},"University of Pennsylvania",{"id":605,"slug":4,"hasResults":11,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":23,"phases":612,"briefSummary":613,"conditions":614,"keywords":615,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":51},"100593448","NCT07006571","At-home Treatment With Cortico-spinal tDCS for Amyotrophic Lateral Sclerosis","Evaluation of the Efficacy of Home-based Transcranial Direct Current Stimulation on Physical Function in Patients With Amyotrophic Lateral Sclerosis: a Randomized, Controlled Clinical Trial","tDCS-ALS","Inclusion Criteria:\n\n* Male or female patients with a probable, laboratory-supported diagnosis of ALS, or defined ALS according to current clinical criteria\n* Age greater than 18 years\n* Onset of disease ≤ 24 months\n* Disease progression in the last 3 months\n* A score ≥ 2 on the \"respiratory failure\" item on the ALS Functional Rating Scale Revised (ALSFRS-R)\n* Treatment with riluzole or edaravone is permitted, provided it has been stable for at least 1 month prior to enrollment in the study, or no ALS-specific treatment\n* Presence of a caregiver who can assist the patient and who has successfully completed the necessary training in the use of the device\n* Signature of informed consent\n\nExclusion Criteria:\n\n* People with fixed electrical stimulators (e.g. cardiac pacemakers, nerve stimulators, hearing implants) that would not work or would be damaged by the electric field;\n* People with particular intracranial metal foreign bodies (e.g. splinters, some prostheses, screws and nails) that could interact with the electric field\n* People with a history of epilepsy;\n* As the effects of tDCS on the developing fetus are not known, pregnant women will be excluded from the study.",{"count":458,"type":22},[62],"Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that causes gradual muscle weakness and loss of muscle mass. It affects all muscles that control movement, speech, swallowing, and breathing. Unfortunately, ALS is currently incurable, and treatments are limited. Only two medications, riluzole and edaravone, have been approved and can slightly extend survival, typically between 20 and 48 months from diagnosis.\n\nRecent research has identified a useful biomarker known as neurofilament light chain (NfL), which increases in the blood as nerve cells become damaged. Measuring NfL levels can help track the progression of ALS.\n\nA promising non-invasive treatment called transcranial direct current stimulation (tDCS) has shown potential benefits for patients with ALS. tDCS involves safely applying mild electrical currents to specific areas of the brain and spinal cord. This approach aims to stimulate nerve cells, potentially improving their function and slowing disease progression. Initial studies have reported temporary improvements in muscle strength and survival when tDCS was used over a short period.\n\nBased on these encouraging results, our study proposes a new home-based tDCS treatment program specifically designed for ALS patients. Participants will use an easy-to-operate, safe, and portable device at home. The treatment involves placing electrodes on the scalp and the neck area to stimulate both the motor areas of the brain and the spinal cord. Therapy sessions will occur five days per week over 16 weeks.\n\nThis home-based approach allows patients to comfortably receive therapy without daily trips to the hospital, making treatment more accessible and convenient. By providing this therapy at home, the investigators aim to improve the quality of life for ALS patients and explore new possibilities in treating and managing ALS and other neurodegenerative diseases.",[31,172],[616,31,609],"At-home tDCS","2025-06-09",{"date":619,"type":43},"2025-06-13",{"date":621,"type":43},"2025-05-19",{"date":623,"type":22},"2029-09-30",{"name":625,"class":133},"University of Trieste",{"id":627,"slug":4,"hasResults":11,"nctId":628,"briefTitle":629,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":297,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":4},"100593511","NCT07007390","Systems Biology of Amyotrophic Lateral Sclerosis (ALS)","Inclusion Criteria:\n\n* Patient of Dr. Espíndola at UFSC\n\nExclusion Criteria:\n\n\\-",{"count":290,"type":22},"The goal of this observational study is to identify molecular features in multiple clinical samples and\u002For the patient environment that are associated with ALS. Participants will collect biological samples and answer questionnaires regarding their health at each appointment with their ALS practitioner.",[31,172],"2025-06-02",{"date":636,"type":43},"2025-06-05",{"date":638,"type":22},"2025-06-01",{"date":640,"type":22},"2030-05-01",{"name":642,"class":105},"Viome",{"id":644,"slug":4,"hasResults":11,"nctId":645,"briefTitle":646,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":11,"sex":17,"minAge":648,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":651,"conditions":652,"keywords":673,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":51},"100531692","NCT06203106","NYSCF Scientific Discovery Biobank","Inclusion Criteria:\n\n* Age 30 days or older.\n* Diagnosis and\u002For medical history of a condition, disease, genetic background, or trait of interest or healthy control.\n* Adults with decisional capacity must provide written informed consent unless physical limitations preclude signing.\n* Adults without decisional capacity to consent must a have diagnosis of Amyotrophic Lateral Sclerosis (ALS), Alzheimer's Disease and Related Dementias (AD\u002FADRD); Batten Disease, Corticobasal Degeneration (CBD), Dementia, Frontotemporal Dementia (FTD), Huntington Disease, Lewy Body Disease, Multiple Sclerosis, Multiple System Atrophy, Parkinson's Disease (PD), Parkinsonism, and\u002For Progressive Supranuclear Palsy, and must provide assent; a legally authorized representative (LAR) must also provide written informed consent.\n* Minors undergoing skin collection for research purposes must have a condition, disease, genetic background, or trait of interest and parental\u002Fguardian consent.\n* Minors undergoing blood, and\u002For saliva collection for research purposes may have a condition, disease, genetic background, or trait of interest or serve as a healthy control and must have an available parent\u002Fguardian to provide consent.\n* Minors transferring biological samples and associated data from a procedure outside of the research may have a condition, disease, genetic background, or trait of interest or serve as a healthy control and must have an available parent\u002Fguardian to provide consent.\n\nExclusion Criteria:\n\n* Wards of the state.\n* For prospective skin samples: history of keloid formation, coagulation disorder, or allergy to the anesthetic.\n* For prospective blood samples: history of coagulation disorder.\n* For all prospective sample collections: 1) Subjects who refuse to adhere to NYSCF's and\u002For a collection site's safety protocol(s) will be excluded; 2) Subjects with an AIDS diagnosis and CD4 count of less than 200 cells per microliter (mcL) of blood will be excluded due to increased risk of infection.","30 Days",{"count":650,"type":22},10000,"The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate diverse disease research using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and store the samples for future use.\n\nThrough this research, researchers hope to identify future treatments or even cures for the major diseases of our time.",[31,81,84,653,654,655,656,29,85,657,86,92,658,588,659,80,660,661,662,663,664,665,666,667,668,669,670,671,672],"Alzheimer Disease, Early Onset","Alzheimer Disease, Late Onset","Batten Disease","Corticobasal Degeneration","Huntington Disease","Multiple System Atrophy","Parkinson's Disease and Parkinsonism","INAD","Diabetes","Diabetes Mellitus","Diabetes Mellitus, Type 2","Diabetes Mellitus, Type 1","Macular Degeneration","Ovarian Cancer","Cervical Cancer","Uterine Cancer","Vaginal Cancer","Vulvar Cancer","PTSD","Post Traumatic Stress Disorder",[31,81,84,655,656,29,85,657,86,92,658,588,674,80,660,661,675,676,665,677,666,667,668,669,670,671,672],"Parkinsonism","Diabetes Type 1","Diabetes Type 2","Women's Reproductive Cancer","2025-02-27",{"date":680,"type":43},"2025-03-03",{"date":682,"type":43},"2022-11-10",{"date":684,"type":22},"2045-11-10",{"name":686,"class":133},"New York Stem Cell Foundation Research Institute",""]