[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568467":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":11,"studyPopulation":11,"armGroups":66,"interventions":78,"overallOfficials":11,"centralContacts":84,"locations":90,"responsibleParty":111,"collaborators":11,"id":113,"slug":11,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":11,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":93,"whyStopped":11,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Parc de Salut Mar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":41},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8.",null,"baseline to week 8",{"measure":14,"description":15,"timeFrame":16},"Change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score","The ALS Functional Rating Scale-Revised Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0.\n\nHigher scores mean a better outcome.","baseline to week 24",[18,21,23,25,28,32,35,38],{"measure":19,"description":11,"timeFrame":20},"Change plasma neurofilament light chain (NfL) levels","baseline to week 4 and 8",{"measure":22,"description":11,"timeFrame":20},"Changes in muscle strength, assessed by the Medical Research Council (MRC) sum score",{"measure":24,"description":11,"timeFrame":12},"Changes in hand-held dynamometry",{"measure":26,"description":11,"timeFrame":27},"Differences (treated vs sham) and change in the slow vital capacity (SVC)","from baseline to month 6",{"measure":29,"description":30,"timeFrame":31},"Differences (treated vs sham) and change in plasma NfL levels","Candidate biomarkers are: SOD1, Ataxin 2, C90rf72, UNC13A, TDP43, stathmin 2, NfL and NfH levels","baseline to month 6",{"measure":33,"description":34,"timeFrame":20},"Change in Motor Evoked Potential (MEP) Amplitudes","ppTMS will be used to assess changes in motor cortex excitability via MEP amplitude (measured in millivolts)",{"measure":36,"description":37,"timeFrame":20},"Change in Resting Motor Threshold","RMT will be recorded to assess baseline motor cortex excitability (measured as a percentage of maximum stimulator output)",{"measure":39,"description":40,"timeFrame":20},"Change in Intra-Cortical Facilitation","ICF will be measured to assess synaptic excitability",[42,44,46,48,50,52,54],{"measure":43,"description":11,"timeFrame":20},"Change in biomarker SOD1 Levels in nEVs from Plasma",{"measure":45,"description":11,"timeFrame":20},"Change in biomarker Ataxin 2 Levels in nEVs from Plasma",{"measure":47,"description":11,"timeFrame":20},"Change in biomarker C9orf72 Levels in nEVs from Plasma",{"measure":49,"description":11,"timeFrame":20},"Change in biomarker UNC13A Levels in nEVs from Plasma",{"measure":51,"description":11,"timeFrame":20},"Change in biomarker TDP43 Levels in nEVs from Plasma",{"measure":53,"description":11,"timeFrame":20},"Change in biomarker Stathmin 2 Levels in nEVs from Plasma",{"measure":55,"description":11,"timeFrame":20},"Change in NfH Levels in nEVs from Plasma",{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":11,"timePerspective":11,"maskingInfo":61},"RANDOMIZED","PARALLEL","randomised, double blind, sham controlled clinical study","TREATMENT",{"masking":62,"maskingDescription":11,"whoMasked":63},"DOUBLE",[64,65],"PARTICIPANT","INVESTIGATOR",[67,73],{"label":68,"type":69,"description":70,"interventionNames":71},"TPS","EXPERIMENTAL","The stimulation will be 20 min duration as indicated in the CE mark approval. Each session involves 6,000 pulses in the hand region of the motor cortex with 3,000 on each side of the brain. The system uses a low energy flux density maximum of 0.25 mJ\u002Fmm2 accordingly with EMA and FDA guidelines (high energy is defined as \\> 0.5 mJ\u002Fmm2). The standard therapy involves 6 sessions in 2 weeks as indicated in the CE mark.",[72],"Device: Transcranial Pulse Stimulation",{"label":74,"type":75,"description":76,"interventionNames":77},"sham","SHAM_COMPARATOR","The transcranial pulse stimulation with the same device and the same protocol uses a membrane on the device that blocks the sound waves. Participants' motor cortex is not stimulated.",[72],[79],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":11},"DEVICE","Transcranial Pulse Stimulation","low intensity shock-waves stimulation of the motor cortex, bilateral",[68,74],[85],{"name":86,"role":87,"phone":88,"phoneExt":11,"email":89},"Alba Leon, MD","CONTACT","+34932 48 30 00","aleonjorba@psmar.cat",[91],{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Hospital del Mar","RECRUITING","Barcelona","Catalonia","08003","Spain","ES",{"type":100,"coordinates":101},"Point",[102,103],2.15899,41.38879,{"lat":103,"lon":102},[106,109],{"name":107,"role":87,"phone":88,"phoneExt":11,"email":108},"Sergio Vidal, MD","sergio.vidal.notari@psmar.cat",{"name":86,"role":110,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":112,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100568467",false,"NCT06681610","Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study","Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial","TPS4ALS","Inclusion Criteria:\n\n* Patients with diagnosis of sporadic ALS (definite or clinically probable) as defined by the World Federation of Neurology revised El Escorial criteria\n* SVC of 50% or greater of estimated measure and presence of measurable motor evoked potential\n* 21 to 80 years old and male or female\n\nExclusion Criteria:\n\n* patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below","ALL","21 Years","80 Years",{"count":124,"type":125},50,"ESTIMATED","INTERVENTIONAL",[128],"NA","The goal of this clinical trial is to assess the efficacy of TPS of the motor cortex on biomarkers and clinical endpoints in patients with ALS. The main questions it aims to answer are:\n\n* Stage 1: Is there a change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8?\n* Stage 2: Is there a change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score?\n\nIn stage 2, researchers will compare the group receiving the stimulation vs the group receiving a sham stimulation to see if there is a difference in motor cortex activity and in the ALSFRS-R score\n\nParticipants will receive either:\n\n* the TPS treatment\n* a sham TPS treatment",[131],"Amyotrophic Lateral Sclerosis (ALS)",[133,131],"Transcranial Pulse Stimulation (TPS)","2024-11-07",{"date":136,"type":137},"2024-11-08","ACTUAL",{"date":139,"type":137},"2024-10-24",{"date":141,"type":125},"2026-12",{"name":5,"class":6},1]