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

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West Virginia University

Status

Enrolling

Conditions

Tourette Syndrome

Treatments

Device: transcranial magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05705999
2211680481

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Active rTMS
Active Comparator group
Description:
Patients receiving active rTMS
Treatment:
Device: transcranial magnetic stimulation
Sham rTMS
Sham Comparator group
Description:
Patients receiving sham rTMS
Treatment:
Device: transcranial magnetic stimulation

Trial contacts and locations

1

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Central trial contact

Jessica Frey, MD

Data sourced from clinicaltrials.gov

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