Tourette SyndromeSTOP-TICNCT05705999
Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT, a Double-blind, Randomized, Controlled Study
A study testing transcranial magnetic stimulation in people with Tourette Syndrome, run by West Virginia University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of Tourette Syndrome
- Moderate Tic Severity at baseline
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
WVU RNI
Morgantown, West Virginia, 26506
Jessica Frey, MD, 304-598-6127, Jessica.frey@hsc.wvu.edu
About this study
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
- Being tested
- transcranial magnetic stimulation
- Keywords
- Tourette Syndrome, Comprehensive Behavioral Intervention for Tics, Transcranial Magnetic Stimulation
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Active comparator | Patients receiving active rTMS Receives: Device: transcranial magnetic stimulation |
| Sham rTMS | Sham comparator | Patients receiving sham rTMS Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start12 Mar 2024
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, Tourette Association of America
- Responsible party
- Principal investigator, Jessica Frey, West Virginia University
- Investigators
- Jessica Frey, MD, Principal investigator, WVU RNI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705999
- Sponsor's protocol ID
- 2211680481
- Acronym
- STOP-TIC
- Status last verified
- Jul 2025
- First submitted
- 21 Jan 2023
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT, a Double-blind, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05705999
- Acronym / sponsor ID
- STOP-TIC / 2211680481
- Conditions
- Tourette Syndrome
- Keywords
- Tourette Syndrome, Comprehensive Behavioral Intervention for Tics, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- University of Florida, Tourette Association of America
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Active comparator | Device: transcranial magnetic stimulationPatients receiving active rTMS |
| Sham rTMS | Sham comparator | Device: transcranial magnetic stimulationPatients receiving sham rTMS |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Diagnosis of Tourette Syndrome
- Moderate Tic Severity at baseline
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulationThe 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 | Device | Active rTMS, Sham rTMS |
Primary outcome
Yale Global Tic Severity Scale (YGTSS)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Tourette Syndrome
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
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Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
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Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Frey, MD principal investigator
WVU RNI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Tourette Syndrome, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Frey, MD (304-598-6127, Jessica.frey@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Global Tic Severity Scale (YGTSS) (time frame: Through study completion, an average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.