[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647060":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":50,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":33,"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 - NAc First","EXPERIMENTAL","Participants will undergo two focused ultrasound (FUS) neuromodulation sessions spaced four weeks apart. Treatments will target the nucleus accumbens and anterior insula. One of the two sessions may include sham exposure or active control sonication.",[13],"Device: Next Generation Dome Helmet (NGDH)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Next Generation Dome Helmet (NGDH)","Focused ultrasound (FUS) neuromodulation delivered using the Next Generation Dome Helmet (NGDH) system under MRI guidance. The device delivers low-intensity pulsed ultrasound to targeted brain regions, including the nucleus accumbens and anterior insula, to modulate neural activity. Participants will undergo two treatment sessions spaced four weeks apart. One session may include sham exposure in which the device is positioned identically but no therapeutic ultrasound energy is delivered.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Nir Lipsman, MD, PhD, FRCSC","CONTACT","(416)-480-6954","Nir.Lipsman@sunnybrook.ca",{"name":28,"role":24,"phone":29,"phoneExt":30,"email":20},"Anusha Baskaran, PhD","416-480-6100","61650",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Toronto","Ontario","M4N 3M5","Canada","CA",{"type":40,"coordinates":41},"Point",[42,43],-79.39864,43.70643,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":29,"phoneExt":48,"email":49},"Soraly Blanco","61519","jaana.leppala@sunnybrook.ca",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Dr. Nir Lipsman","Principal Investigator MD, PHD, FRCSC, FAANS","100647060","safety-and-feasibility-of-next-generation-dome-helmet-ngdh-for-focused-ultrasound-neuromodulation-in-substance-use-disorder-sud-100647060",false,"NCT07684976","Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD)","Assessment of Safety and Feasibility of Focused Ultrasound (FUS) Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Substance Use Disorder (SUD)","Inclusion Criteria:\n\n1. Must be deemed to have capacity to provide informed consent (determined by the investigator)\n2. Age between 18 to 70 (inclusive)\n3. Diagnosis of SUD (cannabis, alcohol, ketamine, stimulant, opioid or nicotine\u002Ftobacco use disorder) in the moderate to severe range according to the DSM-5\n4. Previous ≥2 pharmacotherapy trials for the diagnosed SUD according to guideline-concordant, evidence-based care\n5. On a stable regimen of their psychiatric medications for 30 days before enrolment.\n\nExclusion Criteria:\n\n1. Pregnant or intending to be pregnant during the study\n2. Known active seizure disorder, significant head injury with an imaging verified lesion\n3. Medical illness that is deemed to be unstable or may confound the effects of the intervention\n4. Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)\n5. Unable to reliably attend the required screening, treatment, and follow up appointments.\n6. Severe claustrophobia, identified by the subject to be a limiting factor preventing MRI.\n7. Scores 18 or below on Montreal Cognitive Assessment (MoCA)\n8. Weighs 250 lbs or more.","ALL","18 Years","70 Years",{"count":65,"type":66},20,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of this clinical trial is to evaluate the safety, feasibility, and preliminary clinical benefit of focused ultrasound (FUS) neuromodulation using the FUS Next Generation Dome Helmet (NGDH) in adults with treatment-resistant moderate-to-severe substance use disorder (SUD).\n\nThe main questions it aims to answer are:\n\nCan FUS neuromodulation be safely delivered to the nucleus accumbens (NAc) and\u002For anterior insula (aI)? Does FUS neuromodulation result in reduced substance use severity, as measured by Timeline Followback (TLFB), by 4 weeks post-treatment?\n\nParticipants will:\n\nComplete baseline clinical assessments, questionnaires, imaging, and safety assessments.\n\nUndergo two MRI-guided FUS neuromodulation sessions approximately 4 weeks apart.\n\nAttend follow-up visits for safety monitoring, symptom assessments, quality-of-life measures, and additional imaging where applicable.",[72],"Substance Use Disorder (SUD)",[74,75,76],"Neuromodulation","Focused Ultrasound (FUS)","treatment-refractory substance use disorder","2026-07-02",{"date":79,"type":80},"2026-07-06","ACTUAL",{"date":82,"type":66},"2026-07",{"date":84,"type":66},"2028-07",{"name":5,"class":6},1]