Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders: a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to post-intervention
研究概览
简要总结
This study is a prospective, multicenter, randomized, single-blind controlled trial to enroll 200 children with autism spectrum disorders (ASD). The investigators hope to further explore the effectiveness of accelerated continuous theta-burst stimulation (a-cTBS) over the left primary motor cortex (M1) to improve core symptoms in ASD children based on a previous open-label clinical trial.
详细描述
This study is a prospective, multicenter, randomized, single-blind controlled trial. Shanghai Xinhua hospital, Qilu hospital and Zhengzhou Children's hospital expect to enroll a total of 200 children with autism spectrum disorders (ASD) to participate in this trial.
The children seen at Department of Developmental Behavioral Child Health, who meet the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) ASD diagnostic criteria and strict inclusion/exclusion criteria, can be enrolled for the intervention after informed consent.
At each study center, participants will be randomized into intervention group and sham group stratified by IQ level. The participants, their legal guardians, and the assessors were unaware of the grouping except for the intervention operator (single-blind).
During the trial, participants in intervention group will receive accelerated continuous theta-burst stimulation (a-cTBS) on the left primary motor cortex (M1) for 5 consecutive days. The sham group will be stimulated with a pseudo-stimulation coil, which emitted sounds with the same intensity, rhythm and vibratory sensation as the real stimulation, and the intervention target, duration and frequency are the same as the real intervention group.
All participants need to complete clinical assessments within 2 weeks before the cTBS intervention (pre-cTBS), repeated within 3 days after the completion of the cTBS course (post-cTBS) and 1 month following the last cTBS session (one month follow-up), respectively.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The participants, their legal guardians, and the assessors were unaware of the grouping except for the intervention operator.
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-10 years old
- •Meet the diagnostic criteria for ASD of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- •ASD Diagnosis confirmed by the Autism Diagnostic Observation Schedule (ADOS) or Autism Diagnostic Interview, Revised (ADI-R)
- •IQ of 50 or above
- •Provide written informed consents
排除标准
- •With metal implants in the body
- •History of epilepsy or other neurological disease
- •Require surgical treatment due to structural abnormalities indicated by brain MRI
- •Diagnosed with genetic and chromosomal abnormalities
- •With psychiatric/mental disorder (e.g., very early-onset schizophrenia) other than ASD
- •Suffer from serious heart disease and/or severe hearing impairment
- •Intracranial hypertension
- •Participating in other clinical trials
- •Participants who received other interventions within 4 weeks prior to enrollment.
研究组 & 干预措施
Intervention Group
participants in intervention group will receive accelerated continuous theta-burst stimulation (a-cTBS) on the left primary motor cortex (M1) for 5 consecutive days.
干预措施: repeated transcranial magnetic stimulation (continuous theta-burst stimulation) (Device)
Sham Group
The sham group will be stimulated with a pseudo-stimulation coil, which emitted sounds with the same intensity, rhythm and vibratory sensation as the real stimulation, and the intervention target, duration and frequency are the same as the real intervention group.
干预措施: sham repeated transcranial magnetic stimulation (Device)
结局指标
主要结局
Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to post-intervention
时间窗: within 2 weeks before the intervention (pre-intervention), within 3 days after the completion of the intervention course (post-intervention)
SRS provides the multi-dimensional measure of social interaction allowing the rating of social impairment in ASD. SRS generates a total score and five theoretical subscale scores (labeled social awareness, social cognition, social communication, social motivation, restricted interests and repetitive behavior), and higher scores are indicative of greater social impairment.
Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to 1 month follow-up
时间窗: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)
SRS provides the multi-dimensional measure of social interaction allowing the rating of social impairment in ASD. SRS generates a total score and five theoretical subscale scores (labeled social awareness, social cognition, social communication, social motivation, restricted interests and repetitive behavior), and higher scores are indicative of greater social impairment.
次要结局
- Chinese Communicative Development Inventory (CCDI)(within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up))
- Language Comprehension Test(within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up))
- Multilingual Assessment Instrument for Narratives (MAIN)(within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up))
- Clinical Global Impression Scale (CGI)(within 3 days after the completion of the intervention course (post-intervention), 1 month following the last intervention session (one month follow-up))
- Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)(within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up))
- Electroencephalography (EEG)(within 2 weeks before the intervention (pre-intervention), within 2 days after the completion of the intervention course (post-intervention))
研究者
Fei Li
Chief Physician ,Doctoral Supervisor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine