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NCT06529380Recruiting

Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
25 (estimated)
First submitted
26 Feb 2024
Start date
11 Sept 2024
Primary completion date
31 Dec 2026
Lead sponsor
The Hospital for Sick Children
Diseases
Autism
NCT number
NCT06529380

What you commit to

  • Study type: Interventional
  • Planned participants: 25
  • From 11 Sept 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that may incur significant risk from a surgical procedure.

Other

  • Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine.
  • Any contraindication to MRI scanning.
  • Pregnancy.

Who the study is looking for

  • 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.

Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Hospital for Sick Children
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.