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
The Hospital for Sick Children
25 participants
Sep 11, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria4
- 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.
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Interventions
Electrical stimulation of the nucleus accumbens.
DBS will remain OFF (on at 0V).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06529380