跳至主要内容
临床试验/NCT04128397
NCT04128397已完成不适用

An Exploratory Study of Continuous Theta Burst Stimulation (cTBS) Based on Functional Magnetic Resonance Imaging (fMRI) in the Treatment of Tic Disorder

Second Affiliated Hospital, School of Medicine, Zhejiang University2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2018年6月29日最近更新:
适应症

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

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)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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