Transcranial Magnetic Stimulation for Tourette Syndrome
(STOP-TIC Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: West Virginia University
Disqualifiers: Metallic objects, Pregnancy, Seizures, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12467How 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.
12348Eligibility Criteria
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 am 18 years old or older.
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
+2 more
Trial Timeline
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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
WVU RNIMorgantown, WV
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Who Is Running the Clinical Trial?
West Virginia UniversityLead Sponsor
University of FloridaCollaborator
Tourette Association of AmericaCollaborator
References
Bilateral transcranial magnetic stimulation of the supplementary motor area in children with Tourette syndrome. [2021]To explore the feasibility and possible effects of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered to the supplementary motor area (SMA) on tic severity and motor system neurophysiology in children with Tourette syndrome.
A pilot safety study of repetitive transcranial magnetic stimulation (rTMS) in Tourette's syndrome. [2019]We designed a randomized, blinded, crossover study to assess safety and test whether transcranial magnetic stimulation at specific regions and frequencies might modify tics. We administered repetitive transcranial magnetic stimulation over prefrontal cortex or motor cortex, with either fast or slow repetitive transcranial magnetic stimulation, to 8 Tourette's syndrome patients.
Repetitive transcranial magnetic stimulation for Tourette syndrome. [2019]In a single-blinded, placebo-controlled, crossover repetitive transcranial magnetic stimulation (rTMS) trial, 16 patients with Gilles de la Tourette syndrome (GTS) received in random sequence 1 Hz motor, premotor, and sham rTMS, which each consisted of two 20-minute rTMS sessions applied on 2 consecutive days. In the 12 patients who completed the trial, there was no significant improvement of symptoms after any of the rTMS conditions as assessed with the Motor tic, Obsessions and compulsions, Vocal tic Evaluation Survey.
Subthreshold rTMS over pre-motor cortex has no effect on tics in patients with Gilles de la Tourette syndrome. [2008]A previous study showed no effect of 1Hz repetitive transcranial magnetic stimulation (rTMS) on tics in Gilles de la Tourette Syndrome (GTS). We modified the rTMS protocol in order to investigate some of the possible methodological reasons for the negative outcome in that study.
Randomized Sham Controlled Double-blind Trial of Repetitive Transcranial Magnetic Stimulation for Adults With Severe Tourette Syndrome. [2018]A small proportion of individuals with Tourette syndrome (TS) have a lifelong course of illness that fails to respond to conventional treatments. Open label studies have suggested that low frequency (1-Hz) repetitive transcranial magnetic stimulation (rTMS) targeting the supplementary motor area (SMA) may be effective in reducing tic severity.
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]Studies using repetitive transcranial magnetic stimulation (rTMS) in healthy individuals and those with neuropsychiatric diseases have rapidly increased since the 1990s, due to the potential of rTMS to modulate the cortical excitability in the brain depending on the stimulation parameters; therefore, the safety considerations for rTMS use are expected to become more important. Wassermann published the first safety guidelines for rTMS from the consensus conference held in 1996, and Rossi and colleague then published the second safety guidelines from the multidisciplinary consensus meeting held in Siena, Italy in 2008, on behalf of the International Federation of Clinical Neurophysiology. More than 10 years after the second guidelines, the updated third safety guidelines were recently published in 2021. The general safety guidelines for conventional rTMS have not substantially changed. Because the most frequently used rTMS protocol is conventional (low- and high-frequency) rTMS in research and clinical settings, we focus on reviewing safety issues when applying conventional rTMS with a focal cortical stimulation coil. The following issues will be covered: 1) possible adverse events induced by rTMS; 2) checklists to screen for any precautions and risks before rTMS; 3) safety considerations for dosing conventional rTMS; and 4) safety considerations for using rTMS in stroke and traumatic brain injury.
Deep TMS add-on treatment for intractable Tourette syndrome: A feasibility study. [2018]In a considerable minority of patients who suffer from Tourette syndrome (TS) the disorder persists into adulthood and is associated with severe symptoms and limited therapeutic options. Repetitive transcranial magnetic stimulation (rTMS) to the supplementary motor area (SMA) has shown promising therapeutic results. Deep rTMS is a novel technology that enables deeper non-invasive cortical stimulation. This open-label pilot study is the first to examine the possible role of deep rTMS as add-on treatment for intractable TS.
Tourette syndrome. [2013]This chapter addresses research applications of transcranial magnetic stimulation (TMS) in Tourette syndrome (TS). TS is a primary, idiopathic, neurological disorder characterized by multiple motor and vocal tics of childhood onset, with duration greater than 1 year, and associated in the majority of cases with attention-deficit/hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), and/or other psychiatric disorders. The majority of the chapter is a critical synopsis of case-control studies applying basic single- and paired-pulse TMS techniques to "resting" motor cortex. Newer applications of theta-burst stimulation are also analyzed. A number of intriguing findings have emerged, which may reflect abnormalities in several disrupted inhibitory or modulatory pathways that may underlie the tendency to manifest tics as well as commonly co-occurring problems such as ADHD and OCD. Chapter sections are organized by type of TMS measurement, with each section describing briefly the technique, the pitfalls of the technique with regard to the above-described challenges, the findings in TS using that technique, and the possible implications for those findings in furthering our understanding of TS. Possible future applications for TMS in studying TS are also discussed.