Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

NCT06529380 | Recruiting DMC

• 1 other identifier: REB # 1000081171
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Self-Injurious Behavior; Autism Spectrum Disorder

Keywords

deep brain stimulation; DBS; ASD; SIB; nucleus accumbens

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Self-injurious behaviour log

  Baseline (3 months), weekly during trial

• Repetitive Behaviour Questionnaire-2 (RBQ-2)

  Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks

• Self-Injurious Behavior Questionnaire (SIB-Q)

  Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks

• Pediatric Quality of Life Inventory (PedsQL) Questionnaire

  Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks

• Autism Diagnostic Observation Schedule (ADOS) Assessment questionnaire

  Baseline, 16 weeks, 30 weeks

Study Arms (2)

Group 1 (DBS ON, then OFF)

ACTIVE COMPARATOR

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 OFF, then ON)

PLACEBO COMPARATOR

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

Interventions

DBS ON DEVICE

Electrical stimulation of the nucleus accumbens.

Group 1 (DBS ON, then OFF); Group 2 (DBS OFF, then ON)

DBS OFF DEVICE

DBS will remain OFF (on at 0V).

Group 1 (DBS ON, then OFF); Group 2 (DBS OFF, then ON)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• George M Ibrahim, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George M Ibrahim, MD

CONTACT

416-813-7500; george.ibrahim@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: July 31, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CA (1)