Repetitive Transcranial Magnetic Stimulation to Promote Helpful Self-regulatory Behaviour in Children and Youth With Autism Spectrum Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
This study will evaluate the feasibility of repetitive Transcranial Magnetic Stimulation (rTMS) in Autism Spectrum Disorder (ASD) with self-regulation impairment. Baseline and follow-up participant visits will include behavioral assessments of self-regulation and magnetic resonance imaging (MRI) to determine neurophysiological outcomes before and after rTMS treatment.
详细描述
Children and youth with Autism Spectrum Disorder (ASD) often present with co-morbid impairments in self-regulation (e.g., difficulty managing their emotions) resulting in unhelpful regulatory approaches such as disruptive compulsive, aggressive and self-injurious behaviour. There is an urgent need to establish novel, precise and effective interventions that promote self-regulation and reduce disruptive behaviours. This project will collect pilot data on the effects of repetitive TMS in reducing disruptive behaviours in youth with ASD, in order to inform the design of a follow-up full-scale clinical trial. Youth with ASD who experience clinically significant difficulties with self-regulation and disruptive behaviour will be recruited. Participants will be randomized to rTMS or sham rTMS for 3 weeks. The overall feasibility of the trial will be assessed. The effect of rTMS on the brain mechanisms of self-regulation and clinical improvement in disruptive behaviours will also be measured. Neurophysiological outcomes, including changes in regional brain network activity for inhibition of behaviour, will be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants and outcomes assessor will be blind to rTMS or sham condition.
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with a diagnosis of autism spectrum disorder and self-regulation impairment or challenges
- •Able to participate in rTMS
排除标准
- •Children with autism spectrum disorder but no co-morbid self-regulation disorders.
- •Children with contraindications to TMS (history of seizures, family history of seizures, metal implants)
- •Co-existing neurological conditions (epilepsy, stroke, etc.)
结局指标
主要结局
Recruitment
时间窗: Weeks 1-18
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Blinding success
时间窗: Weeks 1-18
Blinding of participants and their parents/caregivers and required study team members will be assessed using a Blinding Questionnaire indicating the perceived group membership (rTMS/sham)
Adherence
时间窗: Weeks 1-18
90% of participants who complete assessment achieve the target intensity and dose (15 rTMS sessions)
Attrition
时间窗: Weeks 1-18
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
次要结局
- Clinical Measure of Self-Regulation: The Response To Stress Questionnaire - Family Stress(Weeks 1, 6, 18)
- Clinical Measure of Self-regulation: Aberrant Behaviour Checklist - Irritability Subscale(Weeks 1, 6, 18)
- Clinical Measure of Self-regulation: Emotional Regulation Checklist(Weeks 1, 6, 18)
- Inhibitory control(Weeks 1, 6, 18)
- Structural brain changes (magnetic resonance imaging)(Weeks 1, 6, 18)
- Functional brain changes (magnetic resonance imaging)(Weeks 1, 6, 18)
- Clinical Measure of Self-regulation: Emotion Dysregulation Index Reactivity and Dysphoria(Weeks 1, 6, 18)
- Overall Clinical Change(Weeks 1, 6, 18)
研究者
Deryk Beal
Clinician-Scientist
Holland Bloorview Kids Rehabilitation Hospital