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Completed

NCT Number: NCT04128397

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

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.

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Key information

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

center for cognition and brain disorders,HZNU, Hangzhou, Zhejiang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

traditional stimulation site continuous theta burst stimulation (cTBS)

Device

before cTBS treatment, MRI was used to confirm the stimulation site

precise stimulation site cTBS

Device

before cTBS treatment, rs-fMRI was used to confirm the stimulation site

Primary outcomes

  1. Yale Global Tic Severity Scale score

    Time frame: 5 days

    to evaluate clinical change

Secondary outcomes

  1. fMRI

    Time frame: 1 day, 5 days

    local neural activity; functional connectivity

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Hangzhou Normal University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2019
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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