DBS ON: Electrical stimulation of the nucleus accumbens.
DBS OFF: DBS will remain OFF (on at 0V).
Study 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
Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Repetitive Behaviors Scale-Revised (RBS-R) — Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks A 44-item questionnaire that asks parents/caregivers how often a particular behaviour is seen occurring in the participant on a scale of 0-3, as well as a summary measure of how often the repetitive behaviours occur overall on a scale of 1-100.
Higher scores indicate greater severity.
Trial sites (1)
Facility
City
Region
Status
The Hospital for Sick Children
Toronto
Ontario
Recruiting
More The Hospital for Sick Children trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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