[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647237":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":32,"responsibleParty":48,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Focused Ultrasound Neuromodulation","EXPERIMENTAL","Focused Ultrasound Neuromodulation: Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation targeting regions within the cortical-striatal-thalamic circuit (CSTC) implicated in treatment-resistant depression. Treatments will be spaced four weeks apart. All participants will receive the same intervention and will be followed for 4 weeks post-treatment to evaluate clinical outcomes, adverse events, and depression symptoms.",[13],"Device: Next Generation Dome Helmet (NGDH)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Next Generation Dome Helmet (NGDH)","Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation, spaced four weeks apart, using the Next Generation Dome Helmet device. Treatments will target regions within the CSTC circuit identified by advanced MRI scans. Each session will include pre-treatment assessments, precise sonications of deep brain structures, real-time safety monitoring, and post-treatment imaging.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Nir Lipsman, MD, PHD, FRCSC, FAANS","CONTACT","(416)-480-6954","Nir.Lipsman@sunnybrook.ca",{"name":28,"role":24,"phone":29,"phoneExt":30,"email":31},"Anusha Baskaran, PhD","416-480-6100","61650","anusha.baskaran@sunnybrook.ca",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Toronto","Ontario","M4N 3M5","Canada","CA",{"type":41,"coordinates":42},"Point",[43,44],-79.39864,43.70643,{"lat":44,"lon":43},[47],{"name":28,"role":24,"phone":29,"phoneExt":30,"email":31},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Dr. Nir Lipsman","Principal Investigator MD, PHD, FRCSC, FAANS","100647237","safety-and-feasibility-of-fus-next-generation-dome-helmet-ngdh-to-perform-neuromodulation-in-patients-with-treatment-refractory-obsessive-compulsive-disorder-ocd-100647237",false,"NCT07704632","Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)","Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)","Inclusion Criteria:\n\n1. Must be deemed to have the capacity to provide informed consent.\n2. Age 18 to 85 years.\n3. Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria.\n4. Yale-Brown Obsessive Compulsive Scale total score greater than 22.\n5. If taking psychiatric medications, must be on a stable regimen for at least 30 days before enrollment. Psychiatric medications will be continued throughout the study.\n6. Previous trial of at least two first-line antidepressant agents at an adequate dose and duration, as assessed by two psychiatrists.\n7. Previous trial of cognitive behavioural therapy or psychotherapy for OCD for at least 6 weeks.\n\nExclusion Criteria:\n\n1. Pregnant or intending to become pregnant during the study.\n2. Substance use disorder, other than cannabis or nicotine use disorder, of moderate severity or greater, or where the substance is the primary substance of concern, according to DSM-5 criteria.\n3. Known active seizure disorder or significant head injury with an imaging-confirmed lesion.\n4. Unstable medical illness.\n5. Not eligible for 3-Tesla MRI, such as due to an MRI-incompatible pacemaker or other implanted device.\n6. Unable to reliably attend the required screening, treatment, and follow-up visits.\n7. Severe claustrophobia that would prevent MRI scanning.\n8. History of a bleeding disorder or coagulopathy.\n9. Anticoagulant therapy or use of medications known to increase the risk of hemorrhage within the required washout period before treatment, including:\n\n   * Antiplatelet agents or vitamin K antagonist anticoagulants within 7 days of treatment\n   * Non-vitamin K oral anticoagulants within 72 hours of treatment\n   * Heparin-derived compounds within 48 hours of treatment","ALL","18 Years","85 Years",{"count":63,"type":64},20,"ESTIMATED","INTERVENTIONAL",[67],"NA","This study evaluates the safety, feasibility, and preliminary efficacy of focused ultrasound (FUS) neuromodulation delivered using the Next Generation Dome Helmet (NGDH) in participants with treatment-refractory obsessive-compulsive disorder (OCD). Participants will undergo two study sessions, four weeks apart, involving active FUS neuromodulation targeting nodes of the cortico-striato-thalamo-cortical (CTSC) circuit. Outcomes include adverse events, changes in OCD symptom severity, and quality of life.",[70,71,72],"OCD","Obsessive-Compulsive Disorder (OCD)","Obsessive-Compulsive Disorder",[74,75,76],"Focused ultrasound (FUS)","MRgFUS","FUS Neuromodulation","2026-07-10",{"date":79,"type":80},"2026-07-15","ACTUAL",{"date":82,"type":80},"2025-09-23",{"date":84,"type":64},"2027-09",{"name":5,"class":6},1]