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

Not Applicable

Completed

• Conditions: Tourette Syndrome; Tic Disorders
• Interventions: Device: traditional stimulation site continuous theta burst stimulation (cTBS); Device: precise stimulation site cTBS

• Registration Number: NCT04128397
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2018-06-29
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Primary Completion: 2019-10-31
• Study Completion: 2019-12-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. meet the diagnostic criteria of chronic tic disorder or tourette syndrome;
2. Yale Global Tic Severity Scale (YGTSS) score is greater than 20;
3. the symptoms lasted more than 1 year, and the drug regimen was not adjusted within one month;
4. right-handedness;
5. age 6-20 years;
6. able to receive continuous theta burst stimulation (cTBS) therapy, participants and their guardians agree to receive treatment and observation.

Exclusion Criteria

1. age is under 6-year old;
2. can not tolerate MRI or cTBS treatment;
3. adjust medication during treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional stimulation site continuous theta burst stimulation (cTBS)	traditional stimulation site continuous theta burst stimulation (cTBS)	arm: experimental: performing cTBS to tic patients for continuous 5 days ,3 times for a day (0 minute ,15 minute ,60 minute). The stimulation site include left supplementary motor area, right supplementary motor area, left primary motor area, right primary motor area , left superior parietal lobule, right superior parietal lobule. Determination of stimulation target is a common method of determination in previous studies. For example the vertex (Cz) was measured for each patient and the SMA defined at 15% of the distance between inion and nasion anterior to Cz on the sagittal midline.
precise stimulation site cTBS	precise stimulation site cTBS	arm: experimental: performing cTBS to tic patients for 5 days ,3 times for a day (0 minute ,15 minute ,60 minute). The stimulation site include left supplementary motor area, right supplementary motor area, left primary motor area, right primary motor area , left superior parietal lobule, right superior parietal lobule. The stimulation target is determined by the resting-state functional connectivity, which is robust functional connectivity with the GPi or Thalamus.

Primary Outcome Measures

Name	Time	Method
Yale Global Tic Severity Scale score	5 days	to evaluate clinical change

Secondary Outcome Measures

Name	Time	Method
fMRI	1 day, 5 days	local neural activity; functional connectivity

Trial Locations

Locations (2)

center for cognition and brain disorders,HZNU; 🇨🇳 Hangzhou, Zhejiang, China

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hanzhou, Zhejiang, China