Transcranial Magnetic Stimulation for Tourette Syndrome

(STOP-TIC Trial)

Overseen By Jessica Frey, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Disqualifiers: Metallic objects, Pregnancy, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help adults with Tourette Syndrome manage their tics. It tests whether transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate the brain, can enhance the effectiveness of CBIT, a behavioral treatment for tics. Participants will be divided into two groups: one receiving actual rTMS and the other a sham (fake) version, to determine if the real treatment affects tic frequency and severity. Ideal candidates are adults diagnosed with Tourette Syndrome who have moderate tic severity. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for Tourette Syndrome.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that transcranial magnetic stimulation is safe for Tourette Syndrome?

Research shows that repetitive transcranial magnetic stimulation (rTMS), a non-surgical method using magnets to stimulate the brain, appears safe for adults with Tourette's Syndrome. Studies have found that applying rTMS at specific spots and levels does not cause serious side effects. Some individuals might experience mild headaches or discomfort at the application site, but these effects typically resolve quickly. It's important to note that these findings are based on research with adults, and safety may vary for each person. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Magnetic Stimulation (TMS) for Tourette Syndrome because it offers a non-invasive approach to managing symptoms. Unlike standard treatments such as behavioral therapy or medications like antipsychotics, which can have significant side effects, TMS uses magnetic fields to stimulate nerve cells in the brain, potentially reducing tics without the need for medication. This method could provide a quicker, more targeted way to alleviate symptoms, offering hope for individuals seeking alternative options with fewer side effects.

What evidence suggests that transcranial magnetic stimulation is effective for Tourette Syndrome?

This trial will compare the effects of active repetitive transcranial magnetic stimulation (rTMS) with a sham version for patients with Tourette Syndrome (TS). Studies have shown that rTMS can significantly reduce tic severity in people with TS. A review of research found that rTMS helps decrease both tics and the urge to tic. Evidence suggests that rTMS might be a good option for TS patients who experience side effects from medication. However, some studies indicate that while rTMS can help, it might not be as effective as other treatments like deep brain stimulation. Overall, rTMS shows promise in managing TS symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Jessica Frey, MD

Principal Investigator

WVU RNI

Are You a Good Fit for This Trial?

Adults over 18 with Tourette Syndrome and moderate tic severity can join this study. It's not for those with metal in their brain, pregnant individuals, people with seizures or epilepsy history, anyone who can't have an fMRI, or if another condition prevents them from doing CBIT therapy.

Inclusion Criteria

Moderate Tic Severity at baseline

I have been diagnosed with Tourette Syndrome.

Exclusion Criteria

Contraindications to receiving fMRI

Inability to participate in CBIT due to other underlying cognitive or medical condition

Presence of metallic objects or neurostimulators in the brain

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham rTMS followed by eight CBIT sessions

8 weeks

Follow-up

Participants are monitored for changes in tic frequency and severity, and neurophysiological changes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview The trial is testing whether a technique called rTMS enhances the effects of a tic treatment known as CBIT in adults with Tourette's. Participants are randomly assigned to get either real rTMS or a pretend version before starting eight sessions of CBIT.

How Is the Trial Designed?

Group I: Active rTMS Active Control 1 Intervention

Patients receiving active rTMS

Group II: Sham rTMS Placebo Group 1 Intervention

Patients receiving sham rTMS

Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder
• Obsessive Compulsive Disorder

Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Approved in European Union as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Tourette Association of America

Collaborator

Trials

12

Recruited

500+

Published Research Related to This Trial

In a trial involving 16 patients with Gilles de la Tourette syndrome, repetitive transcranial magnetic stimulation (rTMS) did not lead to significant symptom improvement compared to placebo, as assessed by a specific evaluation survey.

The study included a crossover design with three different rTMS conditions (motor, premotor, and sham), but ultimately, the 12 patients who completed the trial showed no notable changes in their tic symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for Tourette syndrome. Münchau, A., Bloem, BR., Thilo, KV., et al.[2019]

In a randomized, blinded, crossover study involving 8 patients with Tourette's syndrome, repetitive transcranial magnetic stimulation (rTMS) was found to be safe, with minimal side effects and no worsening of tics.

Despite the study's design limitations, tic symptoms showed significant improvement over the week, suggesting potential efficacy of rTMS, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot safety study of repetitive transcranial magnetic stimulation (rTMS) in Tourette's syndrome. Chae, JH., Nahas, Z., Wassermann, E., et al.[2019]

In a phase 1 clinical trial involving 10 children with Tourette syndrome, low-frequency repetitive transcranial magnetic stimulation (rTMS) to the supplementary motor area significantly reduced tic severity, as indicated by a decrease in the Yale Global Tic Severity Scale score (p<0.001).

The rTMS treatment was well-tolerated by all participants, demonstrating that this method is feasible and safe for use in children with Tourette syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral transcranial magnetic stimulation of the supplementary motor area in children with Tourette syndrome. Kahl, CK., Kirton, A., Pringsheim, T., et al.[2021]

In a randomized double-blind sham-controlled trial involving 20 adults with severe Tourette syndrome, low frequency rTMS targeting the supplementary motor area did not show a statistically significant reduction in tic severity after 3 weeks compared to sham treatment (17.3% vs. 13.2%; P = 0.27).

However, a subsequent open-label treatment phase for those who initially received active rTMS resulted in a significant 29.7% reduction in tic severity compared to baseline (P = 0.04), suggesting that longer or different stimulation protocols may be more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Sham Controlled Double-blind Trial of Repetitive Transcranial Magnetic Stimulation for Adults With Severe Tourette Syndrome. Landeros-Weisenberger, A., Mantovani, A., Motlagh, MG., et al.[2018]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

In a study involving five patients with Gilles de la Tourette Syndrome, longer trains of 1Hz rTMS applied to the pre-motor cortex did not significantly reduce tic severity, indicating that this specific protocol may not be effective.

The findings suggest that current rTMS protocols require substantial modifications to potentially benefit patients with tics in GTS, as the tested methods did not yield positive results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthreshold rTMS over pre-motor cortex has no effect on tics in patients with Gilles de la Tourette syndrome. Orth, M., Kirby, R., Richardson, MP., et al.[2008]

Deep repetitive transcranial magnetic stimulation (rTMS) is safe for treating Tourette syndrome (TS) in adults, with no significant side effects reported in a pilot study involving 12 patients.

While overall tic severity did not improve for the entire group, a notable subgroup of patients with both TS and obsessive-compulsive disorder (OCD) experienced significant reductions in tic severity, suggesting that deep rTMS may be more effective for specific TS presentations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep TMS add-on treatment for intractable Tourette syndrome: A feasibility study. Bloch, Y., Arad, S., Levkovitz, Y.[2018]

Transcranial magnetic stimulation (TMS) has been applied in research on Tourette syndrome (TS) to explore abnormalities in brain pathways that may contribute to tics and co-occurring disorders like ADHD and OCD.

The chapter reviews various TMS techniques, including single- and paired-pulse methods and theta-burst stimulation, highlighting their potential to enhance our understanding of TS and suggesting future research directions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tourette syndrome. Shahana, N., Gilbert, DL.[2013]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29885862/

Efficacy of repetitive transcranial magnetic stimulation for ... Current study indicates that rTMS has a significant effect on tic and OC symptoms in TS patients.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022395624001316

A meta-analysis of transcranial magnetic stimulation in ... This meta-analysis examined the efficacy of TMS to reduce tic severity in patients with TS. Additionally, it explored the effect of TMS to reduce premonitory ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12266594/

Effectiveness of 40-Session Repetitive Transcranial ... This report suggests that rTMS may be a promising alternative for TS patients with psychiatric comorbidities, particularly those who cannot tolerate medications ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1478503/full

Tourette syndrome and brain stimulation therapy Our analysis revealed both DBS and rTMS improved TS and OCD symptoms, however the effect of rTMS on TS in RCTs was insignificant, suggesting DBS stimulation is ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03844919

TICS: Transcranial Magnetic Stimulation for Intervening in ... Children (N = 50, 6-18 years) with TS will be randomized to either a (1) rTMS+HRT arm, or (2) sham rTMS+HRT. Outcome measures will examine tic severity (primary) ...

6. europepmc.org europepmc.org/article/med/15453520

A pilot safety study of repetitive transcranial magnetic ... Repetitive transcranial magnetic stimulation at these sites, doses, and use parameters appears to be safe in adults with Tourette's syndrome. Further studies ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15453520/

A pilot safety study of repetitive transcranial magnetic ... Conclusions: Repetitive transcranial magnetic stimulation at these sites, doses, and use parameters appears to be safe in adults with Tourette's syndrome.

8. experts.umn.edu experts.umn.edu/en/publications/a-pilot-safety-study-of-repetitive-transcranial-magnetic-stimulat/

A pilot safety study of repetitive transcranial magnetic ... Conclusions: Repetitive transcranial magnetic stimulation at these sites, doses, and use parameters appears to be safe in adults with Tourette's syndrome.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X14003945

Randomized Sham Controlled Double-blind Trial of ... This RCT did not demonstrate efficacy of 3-week SMA-targeted low frequency rTMS in the treatment of severe adult TS.