Recruiting

cTBS

Sponsor:

UCLA

Code:

NCT07839377

Conditions

Tic Disorder

Eligibility Criteria

Sex: All

Age: 15 - 35

Healthy Volunteers: Not accepted

Interventions

cTBS (accelerated continuous theta burst stimulation)

Study Details

Brief 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).

Conditions

Tic Disorder

Study ID

NCT07839377

Start date

Jun 1, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 35

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: M1 (primary motor cortex)

Determine if cTBS to the M1 can reduce CTD symptoms and normalize abnormal network connectivity within the Somato-Cognitive Action Network (SCAN).

experimental: SMA (supplementary motor area)

Determine if cTBS to the SMA can reduce symptoms of CTD and normalize abnormal network connectivity within the Action Mode Network (AMN).

Interventions

cTBS (accelerated continuous theta burst stimulation)

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.

Primary outcome measure

  • To assess the safety and tolerability of repeated theta burst TMS administration in adolescents age 15 - 35 years with CTD. [ Time Frame: All protocol visits (treatment days 1 - 10) ]

Central Contacts and Locations

Central contacts

Andrew M Lee

415-476-7000AndrewMoses.Lee@ucsf.edu

James T McCracken

415-514-5743James.Mccracken@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94107

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • Tic
  • Tics
  • Tourette's
  • Tourette
  • Tourettes
  • Tic Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.