An Exploratory Study of Continuous Theta Burst Stimulation (cTBS) Based on Functional Magnetic Resonance Imaging (fMRI) in the Treatment of Tic Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Yale Global Tic Severity Scale score
研究概览
简要总结
continuous theta burst stimulation (cTBS) is a safe and effective device for Gilles de la Tourette's syndrome treatment. GPi is an agreed curative target of deep brain stimulation. GPi-based functional connectivity peak voxel in the SMA can be the cTBS target.
详细描述
Tic disorder is a common neuropsychiatric disorder in children and adolescents. Medication is not effective and has side effect. Exploring new treatment methods is one of the research pathway of this disease.Continuous theta burst stimulation (cTBS) is relatively safe and effective, and its efficacy in psychiatric diseases has been gradually recognized. However, the results of current researches of tic disorder treatment are varied, and the evaluation method is relatively single. This project intends to adopt fmri-guided stimulation target and navigated cTBS to intervene patients with tics and explore individualized cTBS treatment parameters of tics, including stimulation frequency, intensity, type, time and stimulation target. Previous studies for deep brain stimulation reported that the medial globus pallidus (GPi) showed an obvious curative effect. And a deep brain area can be modulated indirectly by a superficial target via functional connectivity. Therefore, the present study attempts to stimulate the superficial target in supplementary motor area (SMA), lateral motor area (M1) which functionally connected with GPi or thalamus since the thalamus also a commonly reported abnormal brain area of Tic. Combined with clinical symptoms and neuroimaging, the therapeutic effect of cTBS in children with tic disorder was comprehensively evaluated in order to provide a new therapeutic method and a better therapeutic effect for the disease.
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
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 20 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet the diagnostic criteria of chronic tic disorder or tourette syndrome;
- •Yale Global Tic Severity Scale (YGTSS) score is greater than 20;
- •the symptoms lasted more than 1 year, and the drug regimen was not adjusted within one month;
- •right-handedness;
- •age 6-20 years;
- •able to receive continuous theta burst stimulation (cTBS) therapy, participants and their guardians agree to receive treatment and observation.
排除标准
- •age is under 6-year old;
- •can not tolerate MRI or cTBS treatment;
- •adjust medication during treatment.
结局指标
主要结局
Yale Global Tic Severity Scale score
时间窗: 5 days
to evaluate clinical change
次要结局
- fMRI(1 day, 5 days)
