Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children
NCT Number: NCT06529380
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Self-Injurious Behavior|Autism Spectrum Disorder
Interventions: DEVICE: DBS ON|DEVICE: DBS OFF
Sponsor: The Hospital for Sick Children
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: The Hospital for Sick Children, Toronto, Ontario, M5G1X8, Canada

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.

Primary Outcome Measures: 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., 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., Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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., Baseline, 16 weeks, 30 weeks