Clinical trial NCT06529380: Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children
Official title: A Randomized Trial of Deep Brain Stimulation of the Nucleus Accumbens for Severe Self-Injurious Behaviours in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Self-Injurious Behavior
Autism Spectrum Disorder
Keywords: deep brain stimulation
DBS
ASD
SIB
nucleus accumbens
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Repetitive Behaviors Scale-Revised (RBS-R)
timeFrame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Secondary outcomes:
measure: Self-injurious behaviour log
timeFrame: Baseline (3 months), weekly during trial
measure: Repetitive Behaviour Questionnaire-2 (RBQ-2)
timeFrame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
measure: Self-Injurious Behavior Questionnaire (SIB-Q)
timeFrame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
measure: Pediatric Quality of Life Inventory (PedsQL) Questionnaire
timeFrame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
measure: Autism Diagnostic Observation Schedule (ADOS) Assessment questionnaire
timeFrame: Baseline, 16 weeks, 30 weeks
measure: Modified Overt Aggression Scale (MOAS) questionnaire
timeFrame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
measure: The Burden Scale for Family Caregivers - Short Version (BSFC-S) questionnaire
timeFrame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
measure: Functional analysis (FA) assessment
timeFrame: Baseline, 16 weeks, 30 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: George M Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References: