[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556766":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":66,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":26,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 (DBS ON, then OFF)","ACTIVE_COMPARATOR","Group 1: DBS will be switched ON in Block 1 (three months) after the initial four-week post-operative period. The DBS device will then be turned OFF for two weeks (\"washout period\"). The device will remain OFF in Block 2 (three months).",[13,14],"Device: DBS ON","Device: DBS OFF",{"label":16,"type":17,"description":18,"interventionNames":19},"Group 2 (DBS OFF, then ON)","PLACEBO_COMPARATOR","Group 2: DBS will remain OFF in Block 1 (three months) after the initial four-week post-operative period. The device will remain off for two weeks thereafter (\"washout period\"). DBS will be switched ON in Block 2 (three months).",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","DBS ON","Electrical stimulation of the nucleus accumbens.",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"DBS OFF","DBS will remain OFF (on at 0V).",[9,16],[32],{"name":33,"affiliation":5,"role":34},"George M Ibrahim, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","416-813-7500","george.ibrahim@sickkids.ca",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Toronto","Ontario","M5G1X8","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-79.39864,43.70643,{"lat":52,"lon":51},[55,60,64],{"name":56,"role":37,"phone":57,"phoneExt":58,"email":59},"MyLoi Huynh","416-813-7654","309117","myloi.huynh@sickkids.ca",{"name":61,"role":37,"phone":57,"phoneExt":62,"email":63},"Fay Kisteroff","309014","fay.kisteroff@sickkids.ca",{"name":65,"role":34,"phone":26,"phoneExt":26,"email":26},"George Ibrahim",{"type":34,"investigatorFullName":65,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Principal Investigator","100556766","deep-brain-stimulation-for-severe-self-injurious-behaviour-in-children-100556766",false,"NCT06529380","Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children","A Randomized Trial of Deep Brain Stimulation of the Nucleus Accumbens for Severe Self-Injurious Behaviours in Children","Inclusion Criteria:\n\n* Age 5-17 at the time of enrollment\n* DSM-5 diagnosis of Autism Spectrum Disorder\n* History of repetitive self-injurious behaviour, as reported by parents and documented on clinical assessment, either at the time of enrollment into the study or in prior medical records. The definition of self-injury is contextual, but requires ongoing, intermittent or continuous manifestation of self-mediated physical injury to the child.\n* Foreseeable risk of serious future self-harm.\n* Screening by study team for presence automatically reinforced self-injurious behaviour (ASIB) subtype 2 or subtype 3 based on caregiver history.\n* Failure or non-eligibility of medical therapy with ongoing repetitive self-injurious behaviours, at 6 months or more after initiation of therapy.\n* Parents or legal guardians, including caregivers, informed and able to provide written consent.\n* Able to comply with all testing, follow-up visits, and study appointments and protocols for 12 months following the end of the duration of the study.\n\nExclusion Criteria:\n\n* Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine.\n* Any contraindication to MRI scanning.\n* Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that may incur significant risk from a surgical procedure.\n* Pregnancy.","ALL","5 Years","17 Years",{"count":79,"type":80},25,"ESTIMATED","INTERVENTIONAL",[83],"NA","Deep Brain Stimulation for the Treatment of Severe Refractory Self-Injurious Behaviour in Children with Autism Spectrum Disorder: A Randomized Trial\n\nTo evaluate the effectiveness of deep brain stimulation (DBS) of the nucleus accumbens for the treatment of severe refractory, repetitive self-injurious behavior (SIB) in children with Autism Spectrum Disorder. Secondary objectives are to examine the effects of DBS on subtypes of SIB through functional analysis.",[86,87],"Self-Injurious Behavior","Autism Spectrum Disorder",[89,90,91,92,93],"deep brain stimulation","DBS","ASD","SIB","nucleus accumbens","2026-03-23",{"date":96,"type":97},"2026-03-27","ACTUAL",{"date":99,"type":97},"2024-09-11",{"date":101,"type":80},"2026-12-31",{"name":5,"class":6},1]