An Exploratory Study of Transcranial Magnetic Stimulation (TMS) Based on Functional Magnetic Resonance Imaging (fMRI) in the Treatment of Tic Disorder

An Exploratory Study of Transcranial Magnetic Stimulation (TMS) Based on Functional Magnetic Resonance Imaging (fMRI) in the Treatment of Tic Disorder

Sponsors

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator: Hangzhou Normal University

Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Brief Summary

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 current research results of tic disorder treatment by TMS are uneven, and the evaluation method is relatively single. This project intends to adopt fmri-guided stimulation target and navigated TMS to intervene patients with tics and explore individualized TMS treatment parameters of tics, including stimulation frequency, intensity, type, time and stimulation target. Past DBS studies showed that stimulate the medial globus pallidus (GPi) can obtain obvious curative effect, therefore, this study attempts to stimulate the function of the connection with GPi supplementary motor area (SMA), premotor (premotor), primary motor area (M1), sensorimotor area, or functional connectivity with the thalamus frontal, parietal, and succeed in task inhibit twitch activated brain regions, such as DLPFC and inferior parietal lobule. Combined with clinical symptoms and neuroimaging, the therapeutic effect of TMS in children with tic disorder was comprehensively evaluated in order to provide a new therapeutic method and a better therapeutic effect for the disease.

Overall Status Recruiting
Start Date December 7, 2018
Completion Date December 31, 2021
Primary Completion Date December 31, 2021
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
YGTSS score 5days
Secondary Outcome
Measure Time Frame
fMRI 1day
Enrollment 200
Condition
Intervention

Intervention Type: Device

Intervention Name: transcranial magnetic stimulation

Description: before TMS treatment , do fMRI to confirm stimulation site

Arm Group Label: transcranial magnetic stimulation(TMS)

Eligibility

Criteria:

Inclusion Criteria: (1) meet the diagnostic criteria of chronic tic disorder or tourette syndrome; (2) 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 6-64 years; (6) able to receive TMS 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 TMS treatment ;(3) adjust medication during treatment .

Gender: All

Minimum Age: 6 Years

Maximum Age: 64 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jianhua Feng Study Director 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Overall Contact

Last Name: XiaoLong Li

Phone: +8615055693080

Email: [email protected]

Location
Facility: Status: Contact:
center for cognition and brain disorders,HZNU | Hangzhou, Zhejiang, 310000, China Recruiting Xiaolong Li +8615055693080 [email protected]
2nd Affiliated Hospital, School of Medicine, Zhejiang University | Hanzhou, Zhejiang, 310000, China Recruiting Xiaoquan Chen +8613575453681 [email protected]
Location Countries

China

Verification Date

December 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: transcranial magnetic stimulation(TMS)

Type: Experimental

Description: arm:experimental:perform TMS to patients for 5days ,3times a day(0 minute ,15 minute ,60 minute )

Patient Data Yes
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov