Deep Brain Stimulation for Self-Harm in Children with Autism

N/A

Recruiting

Led By George M Ibrahim, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 5-17 at the time of enrollment

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (3 months), weekly during trial

Summary

"This trial aims to study the use of deep brain stimulation in children with Autism Spectrum Disorder who exhibit severe self-injurious behavior. The goal is to see if this treatment can effectively reduce repetitive self-h

Who is the study for?

This trial is for children with Autism Spectrum Disorder who engage in severe, repetitive self-injury that hasn't improved with other treatments. Specific details on eligibility criteria are not provided.

What is being tested?

The study tests the effect of turning deep brain stimulation (DBS) on or off in the nucleus accumbens area of the brain to see if it reduces self-harm behaviors in these children.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, headache, infection risk, and unintended changes in mood or behavior due to brain stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 5 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (3 months), weekly during trial

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (3 months), weekly during trial

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (3 months), weekly during trial for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Repetitive Behaviors Scale-Revised (RBS-R)

Self-Injurious Behavior Questionnaire (SIB-Q)

Secondary study objectives

Autism Diagnostic Observation Schedule (ADOS) Assessment questionnaire

Functional analysis (FA) assessment

Modified Overt Aggression Scale (MOAS) questionnaire

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Group 1 (DBS ON, then OFF)Active Control2 Interventions

Group 1: DBS will be switched ON in Block 1 (three months) after the initial four-week post-operative period. The DBS device will then be turned OFF for two weeks ("washout period"). The device will remain OFF in Block 2 (three months).

Group II: Group 2 (DBS OFF, then ON)Placebo Group2 Interventions

Group 2: DBS will remain OFF in Block 1 (three months) after the initial four-week post-operative period. The device will remain off for two weeks thereafter ("washout period"). DBS will be switched ON in Block 2 (three months).

0 / 1Eligibility criteria met