NCT07114770招募中不适用
Explore the Impacts of One Session and Multiple 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 60 人开始时间: 2025年7月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional MRI (default mode network) - BOLD Signal
研究概览
简要总结
This study aims to establish a personalized theta burst stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation, rTMS) protocol considering autistic idiosyncrasy (interindividual variability).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •for autistic adults:
- •Autistic adults (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.
- •DSM-5 severity level of ASD: level 1 or level 2
- •Inclusion criteria for typically developing control:
- •≥18 years old without autism spectrum disorder
排除标准
- •for all participants:
- •Previous or current severe neurological disorders, especially epilepsy
- •Previous or current severe systemic diseases such as cardiovascular disease, diabetes or hypertension
- •Previous or current severe brain injury
- •Implementation of metal materials such as a pacemaker or medication pump
- •Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder, severe major depressive disorder or substance abuse
- •Pregnancy
- •Intracranial space occupied lesions
- •Previous brain surgery or central nerve system infection
- •Concurrent use of medications which increased the risk of seizure attack
- •Participate in another clinical trial within one month
- •With damaged skin at the stimulated region
- •With multiple sclerosis
- •With large ischemic scars
- •Have experienced sleep disorders during brain stimulation
- •Severe alcoholism
- •Concurrent use of antiepileptic drugs
- •Uncontrollable migraines due to increased intracranial pressure
- •Unsuitable for MRI (e.g. those with claustrophobia)
- •Unsuitable for EEG
- •DSM-5 severity level of ASD: level 3
- •Suicidal ideation within one year
- •Withdrawal criteria:
- •Seizure attack during the study period
- •Autistic symptoms worsened obviously during the study period (change of DSM-5 severity level)
- •Extreme agitation or irritability during the study period
- •Participants request
- •Clinical symptoms worsened obviously during study period
- •Start to use antiepileptic drugs during study period
- •Suicidal ideation or self-harm behaviors during study period
结局指标
主要结局
Functional MRI (default mode network) - BOLD Signal
时间窗: Baseline, Week 1, Week 2
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
MEP amplitude
时间窗: Week 2 (20 minutes post-TBS)
MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.
次要结局
未报告次要终点
研究者
研究点 (1)
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