Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorThe Hospital for Sick Children
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
DBS ON
DeviceElectrical stimulation of the nucleus accumbens.
DBS OFF
DeviceDBS will remain OFF (on at 0V).
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Group 1 (DBS ON, then OFF)Active comparator 2 interventions
Group B: Group 2 (DBS OFF, then ON)Placebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Repetitive Behaviors Scale-Revised (RBS-R)
A 44-item questionnaire that asks parents/caregivers how often a particular behaviour is seen occurring in the participant on a scale of 0-3, as well as a summary measure of how often the repetitive behaviours occur overall on a scale of 1-100. Higher scores indicate greater severity.
Time frame
Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeksSecondary outcomes
1
Self-injurious behaviour log
Parent/caregiver-reported frequency of repetitive self-injurious events over a given time period (i.e. number of events per day)
Time frame
Baseline (3 months), weekly during trial2
Repetitive Behaviour Questionnaire-2 (RBQ-2)
A 20-item parent/caregiver questionnaire that measures the frequency of a child's repetitive, restricted, and sensory behaviours. Questionnaire scores can be added to give a Total Repetitive Behaviours Score, within a minimum score of 20 and a maximum score of 60 (with responses '3' and '4' combined). Higher scores indicate greater severity.
Time frame
Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks3
Self-Injurious Behavior Questionnaire (SIB-Q)
A 25-item scale with Likert-style response options that measures self-injurious behavior among those with developmental disabilities. Scores range from 0 to 100, with higher scores indicating greater severity.
Time frame
Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks4
Pediatric Quality of Life Inventory (PedsQL) Questionnaire
A parent questionnaire designed to evaluate health-related quality of life in children. Scores range from 0 to 92, with higher scores indicating poorer quality of life.
Time frame
Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeksSponsors and contacts
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Source ClinicalTrials.gov