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NCT Number: NCT06529380

Deep Brain Stimulation for Severe Self-Injurious Behaviour 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.

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Key information

Conditions

Self-Injurious Behavior Autism Spectrum Disorder Behavior Behavioral Symptoms Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DBS ON

Device

Electrical stimulation of the nucleus accumbens.

DBS Off

Device

DBS will remain OFF (on at 0V).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

George M Ibrahim, MD

CONTACT

[email protected]

416-813-7500

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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