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Clinical Trials in Canada / NCT06529380
Recruiting Not applicable

Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

NCT06529380 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2024-09-11
Last updated
2026-03-27

Condition(s) studied

Self-Injurious BehaviorAutism Spectrum Disorder

Investigational drug(s) / intervention(s)

DBS ONDBS OFF

DBS ON: Electrical stimulation of the nucleus accumbens.

DBS OFF: DBS will remain OFF (on at 0V).

Study summary

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.

Eligibility

Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Hospital for Sick Children Toronto Ontario Recruiting

More The Hospital for Sick Children trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06529380 on ClinicalTrials.gov ↗ ← All trials in Canada