Recruiting

TMS & CBIT

Sponsor:

West Virginia University

Code:

NCT05705999

Conditions

Tourette Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

transcranial magnetic stimulation

Study Details

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.

Conditions

Tourette Syndrome

Study ID

NCT05705999

Start date

Mar 12, 2024

Status verified date

Jul, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Mar 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active rTMS

Patients receiving active rTMS

sham comparator: Sham rTMS

Patients receiving sham rTMS

Interventions

transcranial magnetic stimulation

The neurostimulation protocol will include 1-Hz rTMS over the bilateral SMA at 110% RMT. The SMA will be identified as 4 cm anterior to the vertex (Cz in standard 10-20 EEG setup). Each session will consist of 6 trains lasting 5 minutes each (300 pulses per train) with an intertrain interval of 1 minute for a total duration of 35 minutes (1800 pulses). Patients will receive 4 sessions each day on 4 consecutive days for a total of 16 sessions. Daily duration of this study protocol should last approximately 170 minutes including a 10-minute break in between each session

Primary outcome measure

  • Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Through study completion, an average of 3 months ]
  • Modified Rush Videotape Tic Rating Scale (mRVTRS) [ Time Frame: Through study completion, an average of 3 months ]

Central Contacts and Locations

Central contacts

Jessica Frey, MD

304-598-6127Jessica.frey@hsc.wvu.edu

Locations

WVU RNI

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Jessica Frey, MD

304-598-6127Jessica.frey@hsc.wvu.edu

More Information

Sponsor

West Virginia University

Last update posted

Jul 18, 2025

Last verified

Jul, 2025

Keywords

  • Tourette Syndrome
  • Comprehensive Behavioral Intervention for Tics
  • Transcranial Magnetic Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia University on 2025-07-18.