An Exploratory Study of Continuous Theta Burst Stimulation (cTBS) Based on Functional Magnetic Resonance Imaging (fMRI) in the Treatment of Tic Disorder
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tic Disorders
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 95
- Locations
- 2
- Primary Endpoint
- Yale Global Tic Severity Scale score
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •age is under 6-year old;
- •can not tolerate MRI or cTBS treatment;
- •adjust medication during treatment.
Outcomes
Primary Outcomes
Yale Global Tic Severity Scale score
Time Frame: 5 days
to evaluate clinical change
Secondary Outcomes
- fMRI(1 day, 5 days)