Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

Launched by THE HOSPITAL FOR SICK CHILDREN · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called deep brain stimulation (DBS) for children with Autism Spectrum Disorder (ASD) who have severe self-injurious behavior (SIB). SIB refers to actions where a child may hurt themselves repeatedly, which can be very distressing for both the child and their family. The goal of the study is to see if DBS, which involves sending small electrical signals to a specific part of the brain, can help reduce these harmful behaviors. The trial is currently recruiting participants aged 5 to 17 who have a diagnosis of ASD and a history of self-injurious behavior that hasn’t improved with other treatments.

If you choose to participate, your child will undergo a thorough screening to ensure they meet the criteria for the study. This includes a review of their medical history and a discussion about their self-injurious behaviors. Participants will be closely monitored throughout the study, which lasts for 12 months, and their families will be involved in the process, providing consent and supporting their child's participation. It's important to note that certain conditions, like heart issues or pregnancy, may exclude someone from being in the trial. Overall, this research aims to find new ways to help children who struggle with these challenging behaviors.

Gender

ALL

Eligibility 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.