Status:
RECRUITING
Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Self-Injurious Behavior
Autism Spectrum Disorder
Eligibility:
All Genders
5-17 years
Phase:
NA
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 stimul...
Detailed Description
The proposed study is a single-center, double-blinded, block-randomized crossover trial. Twenty-five (25) participants will be recruited and enrolled in this trial to undergo bilateral nucleus accumb...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06529380
Start Date
September 11 2024
End Date
December 31 2026
Last Update
June 13 2025
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8