[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524364":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":31,"locations":38,"responsibleParty":77,"collaborators":80,"id":82,"slug":31,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":31,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":31,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":31,"overallStatus":41,"whyStopped":31,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Mclean Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Intermittent theta burst stimulation (iTBS)","ACTIVE_COMPARATOR","Participants complete MRI scanning and cognitive testing followed by rTMS (iTBS pattern) followed by repeat cognitive testing and MRI scanning",[13],"Device: intermittant theta burst stimulation (iTBS)",{"label":15,"type":10,"description":16,"interventionNames":17},"continuous theta burst stimulation (cTBS)","Participants complete MRI scanning and cognitive testing followed by rTMS (cTBS pattern) followed by repeat cognitive testing and MRI scanning",[18],"Device: continuous theta burst stimulation (cTBS)",{"label":20,"type":21,"description":22,"interventionNames":23},"sham rTMS","SHAM_COMPARATOR","Participants complete MRI scanning and cognitive testing followed by sham rTMS followed by repeat cognitive testing and MRI scanning",[24],"Device: sham rTMS",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","intermittant theta burst stimulation (iTBS)","iTBS consists of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses.",[9],null,{"type":27,"name":15,"description":33,"armGroupLabels":34,"otherNames":31},"cTBS consists of 3 pulses at 50 Hz repeated at 5 Hz (every 200ms) continuously for a total of 600 pulses",[15],{"type":27,"name":20,"description":36,"armGroupLabels":37,"otherNames":31},"sham rTMS does not deliver a significant change in magnetic field strength",[20],[39,61],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"McLean Hospital","RECRUITING","Belmont","Massachusetts","02478","United States",{"type":47,"coordinates":48},"Point",[49,50],-71.17867,42.39593,{"lat":50,"lon":49},[53,58],{"name":54,"role":55,"phone":56,"phoneExt":31,"email":57},"Madelaine Nye, B.S.","CONTACT","617-855-2370","mnye@mclean.harvard.edu",{"name":59,"role":60,"phone":31,"phoneExt":31,"email":31},"Kathryn E Lewandowski, Ph.D.","PRINCIPAL_INVESTIGATOR",{"facility":62,"status":41,"city":63,"state":43,"zip":64,"country":45,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Beth Israel Deaconess Medical Center","Boston","02215",{"type":47,"coordinates":66},[67,68],-71.05977,42.35843,{"lat":68,"lon":67},[71,75],{"name":72,"role":55,"phone":73,"phoneExt":31,"email":74},"Madelaine Nye","617-632-7956","mnye@bidmc.harvard.edu",{"name":76,"role":60,"phone":31,"phoneExt":31,"email":31},"Roscoe O Brady, MD, PhD",{"type":60,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Kathryn Eve Lewandowski","Associate Professor of Psychiatry, McLean Hospital",[81],{"name":62,"class":6},"100524364",false,"NCT06107764","Cerebellar Modulation of Cognition in Psychosis","Inclusion Criteria:\n\n* Age between 18-55 years\n* Diagnosis of a psychotic disorder (i.e. schizophrenia or schizoaffective disorder or bipolar disorder type I)\n* Must be able to read, speak and understand English\n* Must be judged by study staff to be capable of completing the study procedures\n* Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.\n\nExclusion Criteria:\n\n* Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month\n* Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:\n\n  * Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis 1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology;\n  * History of fainting spells of unknown or undetermined etiology that might constitute seizures\n  * History of multiple seizures or diagnosis of epilepsy\n  * Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease\n  * Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n  * Metal implants (excluding dental fillings) unless cleared by the responsible covering MD (i.e. MRI compatible joint replacement)\n  * Pacemaker\n  * Implanted medication pump\n  * Vagal nerve stimulator\n  * Deep brain stimulator or transcutaneous electric nerve stimulation unit\n  * Ventriculo-peritoneal shunt\n  * Signs of increased intracranial pressure\n  * Intracranial lesion\n  * History of head injury resulting in prolonged loss of consciousness (\\>15minutes) or neurological sequelae\n  * Pregnancy: All participants capable of becoming pregnant will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study.","ALL","18 Years","55 Years",{"count":91,"type":92},95,"ESTIMATED","INTERVENTIONAL",[95],"NA","The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks).\n\nParticipants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.",[98,99,100,101],"Schizophrenia","Schizoaffective Disorder","Bipolar Disorder I","Psychosis","2026-03-16",{"date":104,"type":105},"2026-03-17","ACTUAL",{"date":107,"type":105},"2024-07-31",{"date":109,"type":92},"2029-12",{"name":5,"class":6},2]