Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT, a Double-blind, Randomized, Controlled Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcranial magnetic stimulation.
- Who it may be relevant to
- Registry conditions: Tourette Syndrome. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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 app
Primary outcome measures
- Yale Global Tic Severity Scale (YGTSS) [Time frame: Through study completion, an average of 3 months]
- Modified Rush Videotape Tic Rating Scale (mRVTRS) [Time frame: Through study completion, an average of 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- WVU RNI — Morgantown
Identifiers
NCT: NCT05705999 · 2211680481