Recruiting
Phase 2

CBIT & TMS

Sponsor:

University of Minnesota

Code:

NCT06678737

Conditions

Tics

Tourette Syndrome

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

Interventions

CBIT +cTBS

CBIT +sham cTBS

Study Details

Brief 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.

Conditions

Tics

Tourette Syndrome

Study ID

NCT06678737

Start date

Feb 27, 2025

Status verified date

May, 2026

Completion date

Jul 15, 2030

Anticipated

Primary completion date

Jul 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

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:

  • 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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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).

sham comparator: Control group

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

Interventions

CBIT +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.

CBIT +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.

Primary outcome measure

  • Tic severity [ Time Frame: pretreatment, 10days, 1,3,6 months ]
  • Tic Suppression Task [ Time Frame: pretreatment, 10days, 1,3,6 months ]
  • Tic symptoms severity [ Time Frame: pretreatment, 10days, 1,3,6 months ]
  • Premonitory Urge for Tics Scale [ Time Frame: pretreatment, 10days, 1,3,6 months ]
  • Emotional and Behavioral functioning [ Time Frame: pretreatment, 3,6 months ]
  • Self- and parent measure of functional impairment [ Time Frame: pretreatment, 10days, 1,3,6 months ]
  • Behavior Rating Inventory of Executive Function [ Time Frame: pretreatment, 1,3,6 months ]

Central Contacts and Locations

Central contacts

Christine Conelea, PhD, LP

612-626-3127cconelea@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Christine Conelea

cconelea@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-05-20.