An interventional study of DBS ON and DBS OFF in Self-Injurious Behavior and Autism Spectrum Disorder, sponsored by The Hospital for Sick Children. Recruiting at 1 site in Canada. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment
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.
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 accumbens DBS. After recovery, participants will be randomized to a 3 month block of active stimulation or the DBS will remain off. After a two week washout period, the participants will cross over to the other group. At the end of the second block, all patients will have their DBS devices activated during an open label period. All participants will have baseline assessments that will be repeated at the end of each block.
Expected study duration is 24 months.
249 studies on the registry are indexed under Self-Injurious Behavior; 92 are open to participants now.
This study's planned enrollment of 25 is below the median of 66 across 212 interventional studies indexed under Self-Injurious Behavior.
Browse Self-Injurious Behavior studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Device: DBS ON · Device: DBS OFF
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).
Device: DBS ON · Device: DBS OFF
Electrical stimulation of the nucleus accumbens.
DBS will remain OFF (on at 0V).
Repetitive Behaviors Scale-Revised (RBS-R)
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.
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Self-injurious behaviour log
Parent/caregiver-reported frequency of repetitive self-injurious events over a given time period (i.e. number of events per day)
Time frame: Baseline (3 months), weekly during trial
Repetitive Behaviour Questionnaire-2 (RBQ-2)
A 20-item parent/caregiver questionnaire that measures the frequency of a child's repetitive, restricted, and sensory behaviours. Questionnaire scores can be added to give a Total Repetitive Behaviours Score, within a minimum score of 20 and a maximum score of 60 (with responses '3' and '4' combined). Higher scores indicate greater severity.
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Self-Injurious Behavior Questionnaire (SIB-Q)
A 25-item scale with Likert-style response options that measures self-injurious behavior among those with developmental disabilities. Scores range from 0 to 100, with higher scores indicating greater severity.
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Pediatric Quality of Life Inventory (PedsQL) Questionnaire
A parent questionnaire designed to evaluate health-related quality of life in children. Scores range from 0 to 92, with higher scores indicating poorer quality of life.
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Autism Diagnostic Observation Schedule (ADOS) Assessment questionnaire
A standardized, activity-based assessment designed to evaluate communication skills, social interaction, and imaginative use of materials in individuals who are suspected to have autism spectrum disorder. Classifications: * Non-spectrum: communication \<1, social interaction \<3, communication + social \<6 * Autism spectrum: communication \>2, AND social interaction \>4, AND communication + social 7-9 * Autism: communication \>3, AND social interaction \>6, AND communication + social \>10 Higher scores indicate a greater presence of behaviours associated with autism spectrum disorder.
Time frame: Baseline, 16 weeks, 30 weeks
Modified Overt Aggression Scale (MOAS) questionnaire
A brief survey of overt aggression. Scores range from 0 to 40, with higher scores indicating greater severity.
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
The Burden Scale for Family Caregivers - Short Version (BSFC-S) questionnaire
A brief survey of parental burden of care. Scores range from 0 to 30, with higher scores indicating a greater burden.
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Functional analysis (FA) assessment
An observation-based behavioural assessment that requires observing and quantifying how self-injurious behaviour (SIB) changes across conditions of a standardized and replicable assessment.
Time frame: Baseline, 16 weeks, 30 weeks
Plan to share: Undecided — De-identified data from the clinical trial will be made available upon reasonable request, subject to institutional approval and, where applicable, the execution of a Data Sharing Agreement. Requests for data access should be directed to the corresponding author.
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