ClinicalTrials.gg
RecruitingNCT06678737Updated May 20, 2026

CBIT+TMS R33 Phase

A Phase 2 interventional study of CBIT +cTBS and CBIT +sham cTBS in Tics and Tourette Syndrome, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by University of Minnesota · Phase 2, Interventional, and Basic science

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 21 Years
Sex
All
01

Study summary

Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth 1 and are associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, peer victimization, and a fourfold increased risk of suicide compared to the general population. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients. However, in these trials, only 52% of children and 38% of adults showed clinically meaningful tic improvement, meaning that 50-60% of patients do not benefit from CBIT. CBIT success relies on an ability to suppress tics that many youth lack. The central aim of CBIT is to enhance voluntary tic suppression. Better tic suppression ability drives CBIT improvement 10 and predicts lower tic burden over the course of illness. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. However, research shows that many youth lack this fundamental tic suppression ability that CBIT aspires to enhance.

This study will examine the clinical and neural effects of a treatment combining Comprehensive Behavioral Intervention for Tics (CBIT) and transcranial magnetic stimulation (TMS) to the supplementary motor area (SMA) in young people with tic disorder.

02

Conditions studied

  • Tics
  • Tourette Syndrome
03

In context

Tics

65 studies on the registry are indexed under Tics; 11 are open to participants now.

This study's planned enrollment of 60 is above the median of 34 across 51 interventional studies indexed under Tics.

Browse Tics studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Youth receiving other forms of psychotherapy will be included provided these treatments are not focused on tics. All concurrent treatments will be monitored during the study period.

Exclusion criteria

Exclusion Criteria:

  • Medical conditions 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 , 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Youth with chronic tics randomized to a combined treatment involving Comprehensive Behavioral Intervention for Tics (CBIT) and inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS). TMS involves theta burst stimulation (cTBS).

    Other: CBIT +cTBS

  • Sham comparator
    Control group

    Youth with chronic tics randomized to CBIT and sham stimulation for TMS

    Other: CBIT +sham cTBS

Interventions

  • OtherCBIT +cTBS

    10 daily sessions of CBIT plus cTBS, with MRI, behavioral, and clinical assessments before and after treatment and at 1-, 3-, and 6-month follow-ups.

  • OtherCBIT +sham cTBS

    10 daily sessions of CBIT plus sham cTBS, with MRI, behavioral, and clinical assessments before and after treatment and at 1-, 3-, and 6-month follow-ups.

06

What researchers measure

Primary outcomes

  1. Tic severity

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

    Time frame: pretreatment, 10days, 1,3,6 months

  2. Tic Suppression Task

    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.

    Time frame: pretreatment, 10days, 1,3,6 months

  3. Tic symptoms severity

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

    Time frame: pretreatment, 10days, 1,3,6 months

  4. Premonitory Urge for Tics Scale

    Self-report measure of intensity of urges to tic

    Time frame: pretreatment, 10days, 1,3,6 months

  5. Emotional and Behavioral functioning

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

    Time frame: pretreatment, 3,6 months

  6. Self- and parent measure of functional impairment

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

    Time frame: pretreatment, 10days, 1,3,6 months

  7. Behavior Rating Inventory of Executive Function

    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.

    Time frame: pretreatment, 1,3,6 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2025 (actual). Primary completion is estimated for Jul 2030, 64 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2024
First posted
Nov 7, 2024
StartActual
Feb 27, 2025
Primary completionEst.
Jul 15, 2030
CompletionEst.
Jul 15, 2030
Last update
May 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06678737
Responsible party
Sponsor
First posted
Nov 7, 2024
Start date
Feb 27, 2025
Primary completion
Jul 15, 2030 (estimated)
Completion
Jul 15, 2030 (estimated)
Last update
May 20, 2026

Study contacts

Christine Conelea, PhD, LP
Contact
cconelea@umn.edu
612-626-3127
Christine Conelea
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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