Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT, a Double-blind, Randomized, Controlled Study

Not Applicable

Recruiting

• Conditions: Tourette Syndrome
• Interventions: Device: transcranial magnetic stimulation

• Registration Number: NCT05705999
• Lead Sponsor: West Virginia University

Brief Summary

This pilot study will investigate the clinical and neurophysiological effects of repetitive transcranial magnetic stimulation (rTMS) followed by comprehensive behavioral intervention for tics (CBIT) in adult patients with Tourette's Syndrome (TS). Two groups of moderate disease severity will be randomized to receive active or sham rTMS targeted to the supplementary motor area (SMA) followed by eight CBIT sessions. The change in tic frequency and severity (primary outcome) and neurophysiological changes (secondary outcome) will be compared between the two groups. The central hypothesis is that low frequency rTMS will augment the effects of CBIT through favorable priming of the SMA network.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-21
• Study First Submitted QC: 2023-01-21
• Study First Posted: 2023-01-31
• Study Start: 2024-03-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-03-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age 18 years or older
• Diagnosis of Tourette Syndrome
• Moderate Tic Severity at baseline

Exclusion Criteria

• Presence of metallic objects or neurostimulators in the brain
• Pregnancy
• History of active seizures or epilepsy
• Contraindications to receiving fMRI
• Inability to participate in CBIT due to other underlying cognitive or medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS	transcranial magnetic stimulation	Patients receiving active rTMS
Sham rTMS	transcranial magnetic stimulation	Patients receiving sham rTMS

Primary Outcome Measures

Name	Time	Method
Yale Global Tic Severity Scale (YGTSS)	Through study completion, an average of 3 months	Tic severity will be measured with YGTSS. YGTSS is a clinician-rated scale used to assess tic severity, scored out of 100 where a higher score indicates greater tic frequency and severity. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics - scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from 0 to 50.
Modified Rush Videotape Tic Rating Scale (mRVTRS)	Through study completion, an average of 3 months	This is a tool used by an objective examiner to quantify the severity of a patient's tics by rating the number of body areas affected, motor tic frequency, phonic tic frequency, motor tic severity, and phonic tic severity, each on a 0 through 4 score by watching a video of the patient. Scored out of 20, where a higher score indicates greater tic severity.

Trial Locations

Locations (1)

WVU RNI; 🇺🇸 Morgantown, West Virginia, United States