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CBIT+TMS for Tics and Tourette Syndrome in Youth

This study is testing two approaches to help young people aged 12 to 21 who have chronic tics or Tourette Syndrome. One group will receive CBIT (Comprehensive Behavioral Intervention for Tics) along with cTBS (continuous theta burst stimulation), a type of brain stimulation. The other group will receive CBIT with a sham (inactive) cTBS. Researchers want to see if adding cTBS to CBIT can improve tic severity and how well participants can suppress their tics. They will measure these improvements before and after treatment, and then again at 1, 3, and 6 months later. The study aims to enroll 60 participants. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 60 participants aged 12-21. Participants will be randomly assigned to receive either CBIT + cTBS or CBIT + sham cTBS.
What's involved
Participants will have 10 daily sessions of CBIT plus either cTBS or sham cTBS. They will also have MRI, behavioral, and clinical assessments before and after treatment, and at 1-, 3-, and 6-month follow-ups.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after treatment, with assessments at 1, 3, and 6 months.

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NCT06678737

CBIT+TMS R33 Phase

Recruiting
PHASE2Ages 12–21InterventionalBasic science
University of Minnesota
~60 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:CBIT +cTBSCBIT +sham cTBS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tic severity
Measured over pretreatment, 10days, 1,3,6 months
+6 more outcomes measured

Conditions

Tics
Tourette Syndrome

Explore related trials

Chronic Tic DisorderTourette Syndrome

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Christine Conelea · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Christine Conelea, PhD, LP
[email protected]
612-626-3127
Email the study team

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Eligibility criteria

Inclusion

Age 12-21 years at time of enrollment.
Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.
At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).
Full scale IQ greater than 70.
Child, consenting parent, and adult participant required to have English fluency and literacy to ensure comprehension of study measures and instructions.
To increase external validity of findings, we will include participants taking psychotropic medications that have been stable for 6 weeks and expect to remain stable for the approximately 3-week intervention protocol (with the exception of those taking neuroleptic/antipsychotic medications). Those who previously received tic-specific therapy will be included if they meet the tic severity criterion.

Exclusion

Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, current pregnancy or girls of childbearing age not using effective contraception, or any other medical condition deemed serious or contraindicated by a study physician.
Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia)
Active suicidality.
Previous diagnosis of psychosis or cognitive disability.
Substance abuse or dependence within the past year.
Concurrent psychotherapy focused on tics.
Neuroleptic/antipsychotic medications.
Pregnant according to the medical history or a urine pregnancy test; and menstruating individuals capable of becoming pregnant and not using a highly effective form of contraception (FDA-approved hormonal contraceptive, IUD, tubal ligation)
Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)

What this trial measures

  • Tic severitypretreatment, 10days, 1,3,6 months

    Yale Global Tic Severity Scale, YGTSS: Gold-standard, clinician-administered tic severity scale. Includes symptom checklist of specific tic types.

  • Tic Suppression Taskpretreatment, 10days, 1,3,6 months

    Direct observation measure of tic suppression ability. In this paradigm, a participant is seated alone in a room in front of a computer capturing a video recording of tic occurrences for later coding by independent raters. TST will consist of two 3-min conditions: 1) free-to-tic (FT): youth is instructed to stay seated and tic freely, a measure of naturally occurring tic frequency (tics per minute); 2) suppression: youth is instructed to suppress tics. Videos will be coded to establish tic frequencies using a computerized behavioral coding program.

  • Tic symptoms severitypretreatment, 10days, 1,3,6 months

    Parent/Adult Tic Questionnaire : Adult-self or parent-report measure of tic symptoms and severity

  • Premonitory Urge for Tics Scalepretreatment, 10days, 1,3,6 months

    Self-report measure of intensity of urges to tic

  • Emotional and Behavioral functioningpretreatment, 3,6 months

    Child/Adult Behavior Checklist: Parent- or adult-self report measuring broad emotional and behavioral functioning

  • Self- and parent measure of functional impairmentpretreatment, 10days, 1,3,6 months

    Patient-Reported Outcomes Measurement Information System (PROMIS-49)

  • Behavior Rating Inventory of Executive Functionpretreatment, 1,3,6 months

    Self- and parent-rated measure of impairment of executive function. Raw scores are converted into standardized T-scores with a mean of 50 and standard deviation of 10, higher scores reflect greater symptom severity.