Actively Recruiting

Phase Not Applicable
Age: 5Years - 17Years
All Genders
NCT06529380

Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

Led by The Hospital for Sick Children · Updated on 2026-03-27

25

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

Who Can Participate

Age: 5Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 5-17 at the time of enrollment
  • DSM-5 diagnosis of Autism Spectrum Disorder
  • History of repetitive self-injurious behaviour, ongoing or intermittent, causing physical injury
  • Foreseeable risk of serious future self-harm
  • Screening indicating presence of subtype 2 or 3 automatically reinforced self-injurious behaviour
  • Failure or non-eligibility of medical therapy with ongoing self-injurious behaviours for 6 months or more
  • Parents or legal guardians able to provide informed written consent
  • Ability to comply with all testing, follow-up visits, and study protocols for 12 months after the study
Not Eligible

You will not qualify if you...

  • 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 posing significant surgical risk
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G1X8

Actively Recruiting

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Research Team

G

George M Ibrahim, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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