20 Participants Needed

Transcranial Magnetic Stimulation for Tourette Syndrome

(STOP-TIC Trial)

JF
Overseen ByJessica Frey, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: West Virginia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is transcranial magnetic stimulation (TMS) safe for humans?

Transcranial magnetic stimulation (TMS), including repetitive TMS (rTMS), has been studied for safety in both healthy individuals and those with various neuropsychiatric conditions. Safety guidelines have been established and updated over the years, indicating that TMS is generally considered safe when proper protocols are followed, though it is important to screen for any individual risks before treatment.12345

How is transcranial magnetic stimulation treatment different from other treatments for Tourette syndrome?

Transcranial magnetic stimulation (TMS) is unique because it uses magnetic fields to stimulate specific areas of the brain, unlike traditional treatments that often involve medication. This non-invasive method targets brain regions associated with tics, offering a different approach compared to drugs that affect the whole body.12467

What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for Tourette Syndrome?

Some studies suggest that low-frequency repetitive transcranial magnetic stimulation (rTMS) targeting specific brain areas like the supplementary motor area (SMA) might help reduce tic severity in Tourette syndrome, although results are mixed and not consistently significant.12478

Who Is on the Research Team?

JF

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

I have been diagnosed with Tourette Syndrome.
Moderate Tic Severity at baseline

Exclusion Criteria

Presence of metallic objects or neurostimulators in the brain
Pregnancy
Contraindications to receiving fMRI
See 2 more

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?
2Treatment groups
Active Control
Placebo Group
Group I: Active rTMSActive Control1 Intervention
Patients receiving active rTMS
Group II: Sham rTMSPlacebo Group1 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

Find a Clinic Near You

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

Citations

Bilateral transcranial magnetic stimulation of the supplementary motor area in children with Tourette syndrome. [2021]
A pilot safety study of repetitive transcranial magnetic stimulation (rTMS) in Tourette's syndrome. [2019]
Repetitive transcranial magnetic stimulation for Tourette syndrome. [2019]
Subthreshold rTMS over pre-motor cortex has no effect on tics in patients with Gilles de la Tourette syndrome. [2008]
Randomized Sham Controlled Double-blind Trial of Repetitive Transcranial Magnetic Stimulation for Adults With Severe Tourette Syndrome. [2018]
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]
Deep TMS add-on treatment for intractable Tourette syndrome: A feasibility study. [2018]
Tourette syndrome. [2013]
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