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

NCT04128397 | Completed

• 1 other identifier: 20181207
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

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.

Conditions

Tic Disorders; Tourette Syndrome

Keywords

continuous theta burst stimulation (cTBS); fMRI

Outcome Measures

Primary Outcomes (1)

• Yale Global Tic Severity Scale score

  to evaluate clinical change

  5 days

Secondary Outcomes (1)

• fMRI

  1 day, 5 days

Study Arms (2)

traditional stimulation site continuous theta burst stimulation (cTBS)

EXPERIMENTAL

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.

Device: traditional stimulation site continuous theta burst stimulation (cTBS)

precise stimulation site cTBS

EXPERIMENTAL

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.

Device: precise stimulation site cTBS

Interventions

traditional stimulation site continuous theta burst stimulation (cTBS) DEVICE

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

traditional stimulation site continuous theta burst stimulation (cTBS)

precise stimulation site cTBS DEVICE

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

precise stimulation site cTBS

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Hangzhou Normal University: collaborator

Study Sites (2)

center for cognition and brain disorders,HZNU

Hangzhou, Zhejiang, 310000, China

Location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hanzhou, Zhejiang, 310000, China

Location

Related Publications (3)

• 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.

  PMID: 29986411 BACKGROUND

• 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.

  PMID: 25912296 BACKGROUND

• 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.

  PMID: 31129620 BACKGROUND

MeSH Terms

Conditions

Tic Disorders; Tourette Syndrome

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jianhua Feng

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: first group is traditional stimulation site group ,second group is precise position stimulation group .

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: June 29, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)