Treatment for chronic tics in youth using behavioral therapy and brain stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cognitive-psychophysiological therapy, with or without biofeedback, for tics in young people with Tourette's

  This project tests whether adding biofeedback to cognitive-psychophysiological therapy helps reduce tics in 14–21-year-olds with Tourette's.

  Recruiting Université du Québec a Montréal · Montreal, Quebec · NCT06873841

• Nature- and activity-based group programs for neurodivergent children and youth in Agder

  This project will try outdoor and activity-based group programs to see if they help children and teens with ADHD, autism, Tourette's, and related neurodivergent challenges feel better, gain confidence, and do better in daily life.

  Recruiting at 2 sites Sorlandet Hospital HF · Kristiansand, Agder and 1 other locations · NCT07203469

• Brain and reflex testing to distinguish organic and functional tics

  This test uses EEG, EMG, blink reflex, and pre-pulse inhibition recordings to see if brain and reflex signals can tell apart adults with organic tics, adults with functional tics, and people without tics.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07137442

• Study of brain activity in patients with Tourette Syndrome

  This study is testing how brain activity changes in adults with severe Tourette Syndrome who are getting deep brain stimulation to better understand their tics.

  Recruiting University Hospital, Bordeaux · Bordeaux · NCT06909656

• Personalized deep brain stimulation for Tourette syndrome

  This study is testing if personalized deep brain stimulation can help people with Tourette syndrome reduce their tics and improve related issues like anxiety and attention problems.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT06889480

• Understanding premonitory urges during tic treatment with Habit Reversal Training

  This study is testing how kids and teens with Tourette Disorder experience changes in their urges to tic while they try a treatment called Habit Reversal Training.

  Recruiting University of Utah · Salt Lake City, Utah · NCT06825520

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.