Recruiting

Deep Brain Stimulation

Sponsor:

The Hospital for Sick Children

Code:

NCT06529380

Conditions

Self-Injurious Behavior

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

DBS ON

DBS OFF

Study Details

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

Study ID

NCT06529380

Start date

Sep 11, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group 1 (DBS ON, then OFF)

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).

placebo comparator: Group 2 (DBS OFF, then ON)

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).

Interventions

DBS ON

Electrical stimulation of the nucleus accumbens.

DBS OFF

DBS will remain OFF (on at 0V).

Primary outcome measure

  • Repetitive Behaviors Scale-Revised (RBS-R) [ Time Frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks ]

Central Contacts and Locations

Central contacts

George M Ibrahim, MD

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

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G1X8

Contacts

MyLoi Huynh

416-813-7654myloi.huynh@sickkids.ca

Fay Kisteroff

416-813-7654fay.kisteroff@sickkids.ca

Principal Investigator:

George Ibrahim

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2026-03-27.