NCT06529380 Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children
| NCT ID | NCT06529380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Self-Injurious Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-09-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2024-09-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
George M Ibrahim, MD
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT06529380 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Self-Injurious Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06529380 currently recruiting?
Yes, NCT06529380 is actively recruiting participants. Contact the research team at george.ibrahim@sickkids.ca for enrollment information.
Where is the NCT06529380 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06529380 clinical trial?
NCT06529380 is sponsored by The Hospital for Sick Children. The principal investigator is George M Ibrahim, MD at The Hospital for Sick Children. The trial plans to enroll 25 participants.