Deep brain stimulation for severe self-injurious behavior in children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of deep brain stimulation (DBS) targeting the nucleus accumbens to treat severe, refractory self-injurious behavior (SIB) in children diagnosed with Autism Spectrum Disorder (ASD). It is a single-center, double-blinded, block-randomized crossover trial involving 20 participants. Each participant will undergo bilateral DBS and will alternate between active stimulation and a control phase without stimulation over a period of 24 months. The study aims to assess the impact of DBS on various subtypes of SIB through functional analysis.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Hospital for Sick Children
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: George M Ibrahim, MD — The Hospital for Sick Children
• Study coordinator: George M Ibrahim, MD
• Email: george.ibrahim@sickkids.ca
• Phone: 416-813-7500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.