Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children
Recruiting now NCT06529380
Run by The Hospital for Sick Children · for 5 to 17 · All sexes
What this study is about
Deep Brain Stimulation for the Treatment of Severe Refractory Self-Injurious Behaviour in Children with Autism Spectrum Disorder: A Randomized Trial To 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.
Who can join (things the study team will check)
✅ You may be able to join if…
- Age 5-17 at the time of enrollment
- DSM-5 diagnosis of Autism Spectrum Disorder
- 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.
- Foreseeable risk of serious future self-harm.
- Screening by study team for presence automatically reinforced self-injurious behaviour (ASIB) subtype 2 or subtype 3 based on caregiver history.
- Failure or non-eligibility of medical therapy with ongoing repetitive self-injurious behaviours, at 6 months or more after initiation of therapy.
- Parents or legal guardians, including caregivers, informed and able to provide written consent.
- 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.
🚫 You may not be able to join if…
- Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine.
- Any contraindication to MRI scanning.
- Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that may incur significant risk from a surgical procedure.
- Pregnancy.
Where this trial is running
- The Hospital for Sick Children, Toronto, Ontario, Canada
Who to contact
George M Ibrahim, MD · 416-813-7500 · george.ibrahim@sickkids.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06529380.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.