Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT, a Double-blind, Randomized, Controlled Study

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
West Virginia University
Study ID
NCT05705999
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • transcranial magnetic stimulation — DEVICE
    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 Details

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.

Key Dates

Start date
Mar 12, 2024
Status verified
Jul 2025
Primary completion
Mar 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active rTMS
    Patients receiving active rTMS
  • Sham Comparator: Sham rTMS
    Patients receiving sham rTMS

Primary Outcome Measure

Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Through study completion, an average of 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
WVU RNIMorgantownWest Virginia26506
Jessica Frey, MD
[email protected]
304-598-6127

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By research site
WVU RNI· Morgantown, WV

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