NCT05578261进行中（未招募）不适用
Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年12月28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
- 10
- 试验地点
- 1
- 主要终点
- Adverse effects report form (Tinnitus)
研究概览
简要总结
The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with autism spectrum disorder (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.
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
- •Concurrent use of medications which increased the risk of seizure attack
- •Participate another clinical trial within one month
- •Skin trauma on application site
- •Individuals suffering from multiple sclerosis
- •Individuals with a large ischemic scar
- •Individuals suffering from sleep deprivation during rTMS procedures
- •Individuals with a heavy consumption of alcohol
- •Current taking antiepileptic drugs
- •Individuals with a migraine headache from increased intracranial pressure
- •Unable to complete MRI scan
- •Withdrawal criteria:
- •Seizure attack during study period
- •Autistic symptoms worsened obviously during study period
- •Extreme agitation or irritability during study period
- •Participants request
- •Take antiepileptic drug during study period
结局指标
主要结局
Adverse effects report form (Tinnitus)
时间窗: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Seizure)
时间窗: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Headache)
时间窗: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Other)
时间窗: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Dizziness)
时间窗: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
次要结局
- MRI T1(Within one month)
- functional MRI (resting-state/biological motion task) - BOLD signal(Within one month)
研究者
研究点 (1)
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