NCT07579494招募中不适用
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
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: 2026年5月5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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •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.
排除标准
- •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.
研究者
研究点 (1)
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