A Randomized Trial of Deep Brain Stimulation of the Nucleus Accumbens for Severe Self-Injurious Behaviours in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Repetitive Behaviors Scale-Revised (RBS-R)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Repetitive Behaviors Scale-Revised (RBS-R)
时间窗: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
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.
次要结局
- Self-injurious behaviour log(Baseline (3 months), weekly during trial)
- Repetitive Behaviour Questionnaire-2 (RBQ-2)(Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks)
- Self-Injurious Behavior Questionnaire (SIB-Q)(Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks)
- Pediatric Quality of Life Inventory (PedsQL) Questionnaire(Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks)
- Modified Overt Aggression Scale (MOAS) questionnaire(Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks)
- Autism Diagnostic Observation Schedule (ADOS) Assessment questionnaire(Baseline, 16 weeks, 30 weeks)
- The Burden Scale for Family Caregivers - Short Version (BSFC-S) questionnaire(Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks)
- Functional analysis (FA) assessment(Baseline, 16 weeks, 30 weeks)
研究者
George Ibrahim
Principal Investigator
The Hospital for Sick Children