NCT06529380

Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study is a single-center, double-blinded, block-randomized crossover trial. Twenty-five (25) participants will be recruited and enrolled in this trial to undergo bilateral nucleus accumbens DBS. After recovery, participants will be randomized to a 3 month block of active stimulation or the DBS will remain off. After a two week washout period, the participants will cross over to the other group. At the end of the second block, all patients will have their DBS devices activated during an open label period. All participants will have baseline assessments that will be repeated at the end of each block. Expected study duration is 24 months.

Conditions

• Self-Injurious Behavior
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	DBS ON	Electrical stimulation of the nucleus accumbens.
DEVICE	DBS OFF	DBS will remain OFF (on at 0V).

Timeline

• Start date: 2024-09-11
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-07-31
• Last updated: 2026-03-27

Locations

1 site across 1 country: Canada