Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07839377

Teen and Adult Tic TMS Study

Conditions: Tic Disorder

Sex: All
Ages: 15 Years – 35 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: University of California, San Francisco

Location: University of California, San Francisco San Francisco California

Summary

This project investigates safety, tolerability, and efficacy signals of accelerated continuous theta burst stimulation (cTBS), a form of inhibitory repetitive transcranial magnetic stimulation (rTMS), for patients with Tourette Syndrome and chronic tic disorders (CTD). It integrates resting-state functional MRI (fMRI) to assess changes in brain circuits and neurophysiology. CTD are neurodevelopmental disorders marked by motor and/or vocal tics, associated with dysfunction in cortico-striato-thalamo-cortical (CSTC) networks, particularly the supplementary motor area (SMA), primary motor cortex (M1), and connected regions. While low-frequency rTMS has shown preliminary benefits in pediatric populations, circuit-targeted approaches remain relatively unexplored in children, adolescents and adults, leaving no consensus about optimal applications. Participants will be randomized to receive 50 sessions of 1800 pulses of cTBS rTMS over two weeks, with five sessions/day targeting the SMA or M1. Assessments will include the Yale Global Tic Severity Scale (YGTSS) and MRI. Aim 1 Determine if cTBS to the M1 can reduce CTD symptoms and normalize abnormal network connectivity within the Somato-Cognitive Action Network (SCAN). Aim 2 Determine if cTBS to the SMA can reduce symptoms of CTD and normalize abnormal network connectivity within the Action Mode Network (AMN).

Eligibility Criteria

Inclusion Criteria: 1. Outpatients 2. Ages 15 - 35 years old 3. Meets DSM-5 criteria for persistent (chronic) vocal/motor tic disorder or Tourette's syndrome with screening YGTSS score ≥ 20 (moderate or greater severity). 4. Moderate severity or intolerable side effects with at least one prior trial of an evidence-based anti-tic medication. 5. Stable on chronic psychotropic medications and/or therapy for 6 weeks prior to the study and agreeable to continue current treatments without change throughout the study. 6. Participants may continue to take medications and record daily usage throughout the study. 7. Capacity to provide informed assent or consent and parent or legal guardian able to provide consent for minors. 8. Ability to tolerate clinical study procedures. 9. Successfully complete the screening forms without any contraindications. Exclusion Criteria: 1. Psychiatric: history of schizophrenia, bipolar disorder, substance /alcohol abuse disorder, current elevated suicide risk, prior psychosurgery. 2. Neurologic: severe neurocognitive disorder, seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, TBI, hydrocephalus, sequelae of meningitis, frank brain injury). 3. TMS contraindications: implanted device; presence of metal in the head, including eyes and ears (excluding dental implants); certain tics. 4. Subjects with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension; malnutrition). 5. Females who are pregnant or nursing (as determined by a questionnaire and urine pregnancy test). 6. Inability to complete the research protocol as determined by the Principal Investigator.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07839377). StuddyBuddy aggregates publicly available trial information.