Deep Brain Stimulation for Autism

Overseen by George Ibrahim, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Hospital for Sick Children

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a device that sends electrical signals to the brain to help children with autism who hurt themselves and don't get better with usual treatments. The device aims to calm the brain areas causing these behaviors. This method has shown promise in treating autism by improving behavior.

Research Team

George Ibrahim, MD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

This trial is for children aged 7-18 with Autism Spectrum Disorder who engage in repetitive self-harm and haven't improved after at least 6 months of medical therapy. Participants must have a caregiver able to consent and commit to all study requirements for one year. Exclusions include pregnancy, inability to complete questionnaires in English, potential relocation, certain health risks from surgery, and recent substance abuse.

Inclusion Criteria

You have a condition where you make repetitive movements that can cause self-injury, as determined by your doctor.

Parents or guardians who are informed and can give written consent.

Parents or legal guardians, including caregivers, informed and able to give written consent

Exclusion Criteria

Pregnancy

Unable to communicate adequately in English in order to complete the baseline and follow-up questionnaires.

Likely to relocate away from the study site or move during the study's one year duration

Treatment Details

Interventions

• DBS (Device)

Trial Overview The trial tests the safety and potential effectiveness of Deep Brain Stimulation (DBS) on the nucleus accumbens in children with autism who self-harm despite treatment. Six patients will receive surgical implantation of the Medtronic DBS system over a one-year pilot phase I trial without blinding or randomization.

Participant Groups

Group I: DBS Treatment Experimental Treatment 2 Interventions

Deep brain stimulation of both limbic and dysfunctional reward processing circuits for treatment of repetitive self injurious behaviours in children with ASD

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Dr. Ronald D. Cohn

The Hospital for Sick Children

Chief Executive Officer since 2019

MD from University of Düsseldorf, Germany

Dr. Lennox Huang

The Hospital for Sick Children

Chief Medical Officer since 2016

MD from McGill University