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Brain stimulation device tested for severe self-injury in children with autism

Tests deep brain stimulation in children aged 5 to 17 with autism and severe self-injury.

Plain-language title generated from the registry record
Registry title: Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

Key facts

Where
Toronto, CanadaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 5 and 17 years old?

Source: NCT06529380, who can take part

Where in Canada

  • The Hospital for Sick ChildrenToronto, CanadaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
The Hospital for Sick Children
Trial code
NCT06529380
Record updated
27 March 2026
Original description
Deep Brain Stimulation for the Treatment of Severe Refractory Self-Injurious Behaviour in Children with Autism Spectrum Disorder: A Randomized TrialRead full original descriptionShow less

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.

Inclusion: 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: Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that may incur significant risk from a surgical procedure; Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine; Any contraindication to MRI scanning; Pregnancy.

ClinicalTrials.gov NCT06529380