Deep brain stimulation for severe self-injurious behavior in children with autism
A Randomized Trial of Deep Brain Stimulation of the Nucleus Accumbens for Severe Self-Injurious Behaviours in Children
This study is testing if deep brain stimulation can help children with autism who struggle with severe self-injurious behavior feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06529380 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-17 with a DSM-5 diagnosis of Autism Spectrum Disorder and a history of severe self-injurious behavior.
Not a fit: Patients who do not exhibit severe self-injurious behavior or have not failed previous medical therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce self-injurious behaviors in children with autism, improving their quality of life.
How similar studies have performed: While deep brain stimulation has been explored in other contexts, this specific application for self-injurious behavior in children with autism is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.