Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT, a Double-blind, Randomized, Controlled Study
NCT ID: NCT05705999
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-03-12
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active rTMS
Patients receiving active rTMS
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 approximately 170 minutes including a 10-minute break in between each session
Sham rTMS
Patients receiving sham rTMS
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 approximately 170 minutes including a 10-minute break in between each session
Interventions
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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 approximately 170 minutes including a 10-minute break in between each session
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Tourette Syndrome
* Moderate Tic Severity at baseline
Exclusion Criteria
* Pregnancy
* History of active seizures or epilepsy
* Contraindications to receiving fMRI
* Inability to participate in CBIT due to other underlying cognitive or medical condition
18 Years
100 Years
ALL
No
Sponsors
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University of Florida
OTHER
Tourette Association of America
OTHER
West Virginia University
OTHER
Responsible Party
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Jessica Frey
Assistant Professor
Principal Investigators
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Jessica Frey, MD
Role: PRINCIPAL_INVESTIGATOR
WVU RNI
Locations
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WVU RNI
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2211680481
Identifier Type: -
Identifier Source: org_study_id
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