- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04128397
An Exploratory Study of Continuous Theta Burst Stimulation (cTBS) Based on fMRI in the Treatment of Tic Disorder
August 2, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
An Exploratory Study of Continuous Theta Burst Stimulation (cTBS) Based on Functional Magnetic Resonance Imaging (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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- center for cognition and brain disorders,HZNU
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Hanzhou, Zhejiang, China, 310000
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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before cTBS treatment, MRI was used to confirm the stimulation site
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Experimental: 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.
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before cTBS treatment, rs-fMRI was used to confirm the stimulation site
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yale Global Tic Severity Scale score
Time Frame: 5 days
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to evaluate clinical change
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5 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fMRI
Time Frame: 1 day, 5 days
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local neural activity; functional connectivity
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1 day, 5 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Jianhua Feng, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Grados M, Huselid R, Duque-Serrano L. Transcranial Magnetic Stimulation in Tourette Syndrome: A Historical Perspective, Its Current Use and the Influence of Comorbidities in Treatment Response. Brain Sci. 2018 Jul 6;8(7):129. doi: 10.3390/brainsci8070129.
- Landeros-Weisenberger A, Mantovani A, Motlagh MG, de Alvarenga PG, Katsovich L, Leckman JF, Lisanby SH. Randomized Sham Controlled Double-blind Trial of Repetitive Transcranial Magnetic Stimulation for Adults With Severe Tourette Syndrome. Brain Stimul. 2015 May-Jun;8(3):574-81. doi: 10.1016/j.brs.2014.11.015. Epub 2014 Dec 3.
- Johnson KA, Fletcher PT, Servello D, Bona A, Porta M, Ostrem JL, Bardinet E, Welter ML, Lozano AM, Baldermann JC, Kuhn J, Huys D, Foltynie T, Hariz M, Joyce EM, Zrinzo L, Kefalopoulou Z, Zhang JG, Meng FG, Zhang C, Ling Z, Xu X, Yu X, Smeets AY, Ackermans L, Visser-Vandewalle V, Mogilner AY, Pourfar MH, Almeida L, Gunduz A, Hu W, Foote KD, Okun MS, Butson CR. Image-based analysis and long-term clinical outcomes of deep brain stimulation for Tourette syndrome: a multisite study. J Neurol Neurosurg Psychiatry. 2019 Oct;90(10):1078-1090. doi: 10.1136/jnnp-2019-320379. Epub 2019 May 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2018
Primary Completion (Actual)
October 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
October 14, 2019
First Submitted That Met QC Criteria
October 14, 2019
First Posted (Actual)
October 16, 2019
Study Record Updates
Last Update Posted (Actual)
August 5, 2022
Last Update Submitted That Met QC Criteria
August 2, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Tourette Syndrome
- Tic Disorders
- Tics
Other Study ID Numbers
- 20181207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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