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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04128397
Enrollment
95
Registered
2019-10-16
Start date
2018-06-29
Completion date
2019-12-31
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tic Disorders, Tourette Syndrome

Keywords

continuous theta burst stimulation (cTBS), fMRI

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.

Interventions

DEVICEtraditional stimulation site continuous theta burst stimulation (cTBS)

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

DEVICEprecise stimulation site cTBS

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

Sponsors

Hangzhou Normal University
CollaboratorOTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

first group is traditional stimulation site group ,second group is precise position stimulation group .

Eligibility

Sex/Gender
ALL
Age
6 Years to 20 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Yale Global Tic Severity Scale score5 daysto evaluate clinical change

Secondary

MeasureTime frameDescription
fMRI1 day, 5 dayslocal neural activity; functional connectivity

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026