Treatment for chronic tics in youth using behavioral therapy and brain stimulation
CBIT+TMS R33 Phase
This study is testing whether combining a special therapy for tics with a type of brain stimulation can help young people with Tourette Syndrome better control their tics.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06678737 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Comprehensive Behavioral Intervention for Tics (CBIT) combined with continuous theta burst stimulation (cTBS) in treating chronic tics associated with Tourette Syndrome in youth aged 12-21. The study aims to enhance voluntary tic suppression, which is crucial for the success of CBIT, as many patients struggle with this ability. Participants will undergo a structured intervention protocol while being monitored for tic severity and overall functioning. The trial includes individuals currently on stable psychotropic medications, allowing for a diverse participant pool.
Who should consider this trial
Good fit: Ideal candidates are youth aged 12-21 with chronic motor and/or vocal tics that have persisted for at least one year.
Not a fit: Patients with tics due to a medical condition or substance effects, or those who are not right-handed, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve tic suppression and overall quality of life for youth with chronic tics.
How similar studies have performed: Previous studies have shown that CBIT is effective, but this combination with cTBS is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Christine Conelea — University of Minnesota
- Study coordinator: Christine Conelea, PhD, LP
- Email: cconelea@umn.edu
- Phone: 612-626-3127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.