Explore the Impacts of Theta Burst Stimulation Over the Right Inferior Frontal Gyrus in Autism Spectrum Disorder: Combination of Clinical Symptoms, Neuropsychological Function and MRI
2026年5月5日 更新者：Chang Gung Memorial Hospital
Exploring the therapeutic efficacy of Theta Burst Stimulation (TBS) over the right inferior frontal gyrus (RIFG) in autism, including changes in core symptoms, adaptive functioning, neuropsychological performance, and neurophysiological signals.
研究概览
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Hsing-Chang Ni, Ph.D
- 电话号码：2479 88633281200
- 邮箱：alanni0918@yahoo.com.tw
学习地点
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Taoyuan、台湾
- 招聘中
- Chang Gung Memorial Hospital
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接触：
- Hsing Chang Ni, PhD
- 电话号码：2479 886-3-3281200
- 邮箱：alanni0918@yahoo.com.tw
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首席研究员：
- Hsing Chang Ni, PhD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Participants aged 8 to 30 years with a clinical diagnosis of Autism Spectrum Disorder (ASD), confirmed by the ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition).
- DSM-5 severity level of ASD: level 1 or level 2
- Participants who have been on a stable treatment regimen prior to the study, or those for whom conventional treatments have been assessed as ineffective by a physician, or those who decline conventional treatment.
- A score of ≥ 15 on the University of California Brief Assessment of Capacity to Consent (UBACC) and demonstrated understanding of study aims and risks via the teach-back method.
Exclusion Criteria:
- Previous or current severe neurological disorders, especially epilepsy, visual or auditory impairments
- 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 or substance abuse
- Pregnancy
- Presence of significant brain abnormalities, such as intracranial space-occupying 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
- Current major depressive disorder
- Suicidal ideation within one year
- Currently taking tricyclic antidepressants (TCAs), analgesics, or any medications known to lower the seizure threshold.
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
- Changes in the frequency or dosage of concurrent treatments during the study period.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Active
Participants received the intervention of iTBS (The total pulse of every session is 600 pulses) over right inferior frontal gyrus for 4 weeks (5 days/week). *iTBS = intermittent theta burst stimulation |
刺激方案
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假比较器：Sham
Participants received the sham intervention of iTBS (sham-coil) over right inferior frontal gyrus for 4 weeks (5 days/week).
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刺激方案
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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社会反应量表总分变化
大体时间：基线； TBS 后（基线后 4 周）；一个月随访（基线后 8 周）；两个月的跟进（基线后 12 周）
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社会反应量表可以测量自闭症的临床严重程度，范围为65-260。
较低的分数代表更好的社会反应能力。
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基线； TBS 后（基线后 4 周）；一个月随访（基线后 8 周）；两个月的跟进（基线后 12 周）
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重复行为量表-修订版总分变化
大体时间：基线； TBS 后（基线后 4 周）；一个月随访（基线后 8 周）；两个月的跟进（基线后 12 周）
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重复行为量表修订版是一份侧重于重复行为的问卷。
得分范围为 0-129。
较低的分数代表较低的重复行为。
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基线； TBS 后（基线后 4 周）；一个月随访（基线后 8 周）；两个月的跟进（基线后 12 周）
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
情绪失调量表总分变化
大体时间：基线； TBS 后（基线后 4 周）；一个月随访（基线后 8 周）；两个月的跟进（基线后 12 周）
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情绪失调量表是家长情绪失调的报告问卷。
得分范围为 0-120。
较低的分数代表更好的情绪调节。
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基线； TBS 后（基线后 4 周）；一个月随访（基线后 8 周）；两个月的跟进（基线后 12 周）
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儿童行为量表总分变化
大体时间：基线； TBS 后（基线后 4 周）；一个月随访（基线后 8 周）；两个月的跟进（基线后 12 周）
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CBCL 是针对行为和情绪问题的家长报告问卷。
较低的分数代表更好的行为和情绪调节。
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基线； TBS 后（基线后 4 周）；一个月随访（基线后 8 周）；两个月的跟进（基线后 12 周）
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Raven 的渐进矩阵
大体时间：基线； TBS 后（基线后 4 周）；一个月随访（基线后 8 周）；两个月的跟进（基线后 12 周）
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执行功能的高级测试。
共60题，答对越多，执行力越好。
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基线； TBS 后（基线后 4 周）；一个月随访（基线后 8 周）；两个月的跟进（基线后 12 周）
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Changes of total scores of Anxiety Scale for Autism
大体时间：baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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ASA is a parents' report questionnaire for severity of anxiety in children with ASD.
The score ranges from 0-72.
The lower scores stand for better emotional regulation.
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baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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Changes of total scores of Adaptive Behavior Assessment System
大体时间：baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior.
The score ranges from 40-120.
The higher scores stand for better adaptive behavior.
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baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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Accuracy of Frith-Happe Animation
大体时间：baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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A quick and objective test of Theory of Mind.
8 questions in total, the more correct questions stand for better social cognition.
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baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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Accuracy of Eyes Task
大体时间：baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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An advanced test for Theory of Mind.
43 questions in total, the more correct questions stand for better social skills.
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baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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Accuracy of Wisconsin Card Sorting Test
大体时间：baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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An advanced test for cognitive flexibility.
128 questions in total, the more correct questions stand for better cognitive flexibility.
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baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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Changes of total scores of Behavior Rating Inventory of Executive Function
大体时间：baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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Behavior Rating Inventory of Executive Function is a parents' report questionnaire for executive function.
The score ranges from 20-110.
The lower scores stand for better executive function.
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baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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MRI T1
大体时间：baseline; post TBS (4 weeks after baseline)
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Brain structural volumes (cm²).
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baseline; post TBS (4 weeks after baseline)
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Functional MRI (Resting-state/Biological Motion Task) - BOLD Signal
大体时间：baseline; post TBS (4 weeks after baseline)
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Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
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baseline; post TBS (4 weeks after baseline)
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DTI Mean-FA Tractometry - Left Arcuate Fasciculus (AF_left)
大体时间：baseline; post TBS (4 weeks after baseline)
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This outcome is the mean fractional anisotropy (FA) of the left arcuate fasciculus (AF_left) computed using DTI-based tractometry.
FA is a unitless metric (range 0-1) that reflects the degree of diffusion anisotropy.
A diffusion tensor was fitted to the diffusion MRI data to generate FA maps, and FA values were sampled within the AF_left tract mask/tract reconstruction and averaged to yield one mean FA value per participant per time point.
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baseline; post TBS (4 weeks after baseline)
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Electroencephalography
大体时间：baseline; post TBS (4 weeks after baseline)
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Resting state EEG (alpha power / frontal gamma power).
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baseline; post TBS (4 weeks after baseline)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月5日
初级完成 (估计的)
2030年7月31日
研究完成 (估计的)
2030年12月31日
研究注册日期
首次提交
2026年5月5日
首先提交符合 QC 标准的
2026年5月5日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年5月12日
上次提交的符合 QC 标准的更新
2026年5月5日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 202401962A0
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