Efficacy and Mechanism of Repeated Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder: an Open-label Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Social Response Scale (SRS)
研究概览
简要总结
This study is a 6-week open-label clinical trial involving 20 children aged 6-10 years with autism spectrum disorder. During the study, subjects received repeated transcranial magnetic stimulation（rTMS）intervention at the left primary motor cortex (M1) 5 times per day for 10 days. From the beginning of intervention to the end of 4 weeks after the completion of intervention, the subjects's clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up.Our purpose is to explore whether rTMS can improve the clinical symptoms of children with autism spectrum disorder in China, and to explore the neurophysiological mechanism of rTMS for autistic children.
详细描述
Participants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). If feasible for the participant, all stimulation sessions will be held at the same time of the day. During this study，participants' clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up for four times, specifically，before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-10 years.
- •Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Edition 5 (DSM-5) .
- •Confirmed by the ADOS and/or ADI-R diagnostic tool.
- •Informed consent.
排除标准
- •Patients with metal implants .
- •Patients with neurological diseases such as epilepsy .
- •Patients requiring surgical treatment due to structural abnormalities indicated by brain MRI .
- •Genetic or chromosomal abnormalities .
- •Suffering from mental disorders (such as mood disorders, etc.)
- •Suffering from serious heart disease .
- •Hearing-impaired .
- •Intracranial hypertension .
- •Participating in other clinical trials.
- •Participants who received other interventions within 4 weeks prior to enrollment.
结局指标
主要结局
Social Response Scale (SRS)
时间窗: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
SRS is a questionnaire used to assess the presence and severity of social impairment, with high scores indicating severe symptoms. Change of the SRS from baseline to 3 month after treatment to evaluate the effect of computer social interaction treatment on ASD children.
次要结局
- ADHD Rating Scale(Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention)
- Clinical Efficacy Rating Scale (CGI)(5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention)
- Behavior Rating Inventory of Executive Function(BRIEF)(Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention)
- Childhood Autism Rating Scale (CARS)(Before intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention)
- Repetitive Stereotyped Behavior - Revised (RBS-R)(Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention)
研究者
Fei Li
Chief Physician ,Doctoral Supervisor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine