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临床试验/NCT04993144
NCT04993144Unknown不适用

To Explore the Therapeutic Effects of Continuous Theta-burst Stimulation Over Left Dorsolateral Prefrontal Cortex in Autism Spectrum Disorder

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年12月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Changes of total scores of Repetitive Behavior Scale-Revised

研究概览

简要总结

The investigator would like to investigate the impact of theta burst stimulation over left dorsolateral prefrontal cortex 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

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 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.

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.

次要结局

  • MRI T1(baseline; post TBS (8 weeks after baseline))
  • 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))
  • Changes of total scores of Vineland Adaptive Behavior Scales(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))
  • Changes in accuracy of Wisconsin Card Sorting Test(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))
  • Autism Diagnostic Observation Schedule - Generic(baseline; post TBS (8 weeks after baseline))
  • 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 Adaptive Behavior Assessment System(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))
  • Raven's Progressive Matrices(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))

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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