Status:
RECRUITING
Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics
Lead Sponsor:
University of Minnesota
Conditions:
Tourette Syndrome
Persistent Tic Disorder
Eligibility:
All Genders
10-17 years
Phase:
PHASE2
Brief Summary
Tourette Syndrome and Persistent Motor/Vocal Tic Disorder affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of ...
Eligibility Criteria
Inclusion
- Age 10-17 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 participant required to have English fluency 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 study period. Individuals receiving non-tic related psychotherapy involving procedures that overlap with CBIT can be eligible to participate if they refrain from receiving treatment once enrolled through the post-treatment assessment. All concurrent treatments will be monitored.
Exclusion
- Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG.
- Active suicidality Previous diagnosis of psychosis, cognitive disability, or structural brain disease that in the investigator opinion would impede participation.
- History of seizure disorder
- Active substance abuse or dependence.
- Presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met, as only 10-15% of patients with TS have no comorbidities.
- Concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
- Psychotropic medication changes in the past 6 weeks and/or plans to change medication during the study period through post-treatment assessment.
- ≥ 4 previous sessions of CBIT.
Key Trial Info
Start Date :
April 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 19 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06194305
Start Date
April 25 2024
End Date
February 19 2029
Last Update
July 14 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California
San Diego, California, United States, 92093
2
University of Minnesota
Minneapolis, Minnesota, United States, 55414