NCT04987749Unknown不适用
To Explore the Therapeutic Effects of Theta Burst Stimulation Over Right Inferior Frontal Gyrus in Autism Spectrum Disorder
Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes of total scores of Social Responsiveness Scale
研究概览
简要总结
The investigator would like to investigate the impact of theta burst stimulation over right inferior frontal gyrus in autism spectrum disorder
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, Care Provider)
入排标准
- 年龄范围
- 8 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •autism spectrum disorder, confirmed by ADOS
排除标准
- •current and past systemic disease
- •current and past major psychiatric disorders including schizophrenia, bipolar affective disorder and major depressive disorder
- •current and past brain injuries
- •intelligence < 70
- •seizure history
结局指标
主要结局
Changes of total scores of Social Responsiveness Scale
时间窗: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.
Changes of total scores of Repetitive Behavior Scale-Revised
时间窗: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The score ranges from 0-129. The lower scores stand for lower repetitive behavior.
次要结局
- Changes of total scores of Emotional Dysregulation Inventory(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
- Changes of total scores of Behavior Rating Inventory of Executive Function(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
- MRI T1(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
- Diffusion Tensor Imaging (DTI) - FA(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
- Changes in accuracy of Frith-Happe animation(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
- Autism Diagnostic Observation Schedule - Generic(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
- Changes of total scores of Adaptive Behavior Assessment System(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
- functional MRI (resting-state/biological motion task) - BOLD signal(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
- Changes in accuracy of Eyes task(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
- Changes in accuracy of Wisconsin Card Sorting Test(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
- Raven's Progressive Matrices(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
- Electroencephalography(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
研究者
研究点 (2)
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