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

NCT ID: NCT05705999

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2026-12-30

Brief Summary

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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

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Conditions

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Tourette Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active rTMS

Patients receiving active rTMS

Group Type ACTIVE_COMPARATOR

transcranial magnetic stimulation

Intervention Type 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

Sham rTMS

Patients receiving sham rTMS

Group Type SHAM_COMPARATOR

transcranial magnetic stimulation

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role collaborator

Tourette Association of America

OTHER

Sponsor Role collaborator

West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Jessica Frey

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Frey, MD

Role: PRINCIPAL_INVESTIGATOR

WVU RNI

Locations

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WVU RNI

Morgantown, West Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Frey, MD

Role: CONTACT

304-598-6127

Facility Contacts

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Jessica Frey, MD

Role: primary

304-598-6127

Other Identifiers

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2211680481

Identifier Type: -

Identifier Source: org_study_id

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