NCT05578209进行中（未招募）不适用
Therapeutic Impacts of Theta Burst Stimulation Over Bilateral Posterior Superior Temporal Sulcus in Autism Spectrum Disorder: a Comprehensive Study Integrating Clinical Symptoms, Neuropsychological Function and MRI
Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 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 intermittent theta burst stimulation over bilateral posterior superior temporal sulcus 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, Investigator)
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
- 否
入选标准
- •Autism spectrum disorder, confirmed by Autism Diagnostic Observation Schedule II (CSS≧6)
- •No change in psychiatric drugs within one month
排除标准
- •Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment
- •Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection
- •Previous or current severe brain injury
- •Implementation of metal materials such as pacemaker or medication pump
- •Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
- •Pregnancy
- •Individuals with a significant brain abnormality such as intracranial space occupied lesions
- •History of brain surgery or nervous system infection, such as meningitis and encephalitis
- •Previous febrile seizures
- •Concurrent use of medications which increased the risk of seizure attack.
- •Participate another clinical trial within one month.
- •Unable to complete MRI scan (claustrophobia)
- •Skin trauma on application site
- •Individuals with a large ischemic scar
- •Individuals suffering from multiple sclerosis
- •Individuals suffering from sleep deprivation during rTMS procedures
- •Individuals with a heavy consumption of alcohol
- •Individuals with a migraine headache from increased intracranial pressure
结局指标
主要结局
Changes of total scores of Social Responsiveness Scale
时间窗: baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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 (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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 (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
- Changes of total scores of Aberrant Behavior Checklist(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
- Changes of total scores of Child Behavior Checklist(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
- Changes of total scores of Adaptive Behavior Assessment System(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
- Changes in accuracy of Frith-Happe animation(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
- Changes of total scores of Behavior Rating Inventory of Executive Function(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
- Raven's Progressive Matrices(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
- Changes in accuracy of Eyes task(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
- Changes in accuracy of Wisconsin Card Sorting Test(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
- functional MRI (resting-state/biological motion task) - BOLD signal(baseline; post TBS (4 weeks after baseline))
- MRI T1(baseline; post TBS (4 weeks after baseline))
- Diffusion Tensor Imaging (DTI) - FA(baseline; post TBS (4 weeks after baseline))
- Electroencephalography(baseline; post TBS (4 weeks after baseline))
研究者
研究点 (1)
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