Deep Brain Stimulation Clinical Trials

Clinical trials related to Deep Brain Stimulation Procedure

A Randomized Trial of Deep Brain Stimulation of the Nucleus Accumbens for Severe Self-Injurious Behaviours in Children

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
The Hospital for Sick Children
RECRUITING
Toronto
Contact Information
Primary
George M Ibrahim, MD
george.ibrahim@sickkids.ca
416-813-7500
Time Frame
Start Date: 2024-09-11
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 25
Treatments
Active_comparator: Group 1 (DBS ON, then OFF)
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).
Placebo_comparator: Group 2 (DBS OFF, then ON)
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).
Sponsors
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov