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

NCT05705999 | Recruiting FDA Device

• 1 other identifier: 2211680481
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Yale Global Tic Severity Scale (YGTSS)

  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.

  Through study completion, an average of 3 months

• Modified Rush Videotape Tic Rating Scale (mRVTRS)

  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.

  Through study completion, an average of 3 months

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

Patients receiving active rTMS

Device: transcranial magnetic stimulation

Sham rTMS

SHAM COMPARATOR

Patients receiving sham rTMS

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

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

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead
• University of Florida: collaborator
• Tourette Association of America: collaborator

Study Sites (1)

WVU RNI

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Tourette Syndrome

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Jessica Frey, MD

  WVU RNI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Frey, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: January 31, 2023
• Study Start: March 12, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)