Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children (DBS-NACC)

March 23, 2026 updated by: George Ibrahim, The Hospital for Sick Children

A Randomized Trial of Deep Brain Stimulation of the Nucleus Accumbens for Severe Self-Injurious Behaviours in Children

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • Recruiting
        • The Hospital for Sick Children
        • Principal Investigator:
          • George Ibrahim
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Device: DBS ON
Electrical stimulation of the nucleus accumbens.
Device: DBS OFF
DBS will remain OFF (on at 0V).
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).
Device: DBS ON
Electrical stimulation of the nucleus accumbens.
Device: DBS OFF
DBS will remain OFF (on at 0V).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repetitive Behaviors Scale-Revised (RBS-R)
Time Frame: 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.
Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional analysis (FA) assessment
Time Frame: Baseline, 16 weeks, 30 weeks
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
Self-Injurious Behavior Questionnaire (SIB-Q)
Time Frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks

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
Repetitive Behaviour Questionnaire-2 (RBQ-2)
Time Frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks

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
Time Frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks

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
Time Frame: Baseline, 16 weeks, 30 weeks

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
Time Frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
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
Time Frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
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
Self-injurious behaviour log
Time Frame: Baseline (3 months), weekly during trial
Parent/caregiver-reported frequency of repetitive self-injurious events over a given time period (i.e. number of events per day)
Baseline (3 months), weekly during trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: George M Ibrahim, MD, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB # 1000081171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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