NCT06194305 Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics
| NCT ID | NCT06194305 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Minnesota |
| Condition | Tourette Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-25 |
| Primary Completion | 2029-02-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-04-25 with a primary completion date of 2029-02-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 life, and peer victimization. Chronic tics are the primary symptom. Comprehensive Behavioral Intervention for Tics (CBIT) is a manualized treatment focused on tic management skills. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. The overall objective of this study is to identify bio-behavioral predictors and correlates of response and the most potent aspects of CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Neural, behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded. CBIT process will be measured with a video-based behavioral coding scheme that will be refined and validated during years 1-2 using archival CBIT videos
Eligibility Criteria
Inclusion Criteria: * 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 4 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 Criteria: * 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 4 weeks and/or plans to change medication during the study period through post-treatment assessment. * ≥ 4 previous sessions of CBIT.
Contact & Investigator
Christine Conelea, PhD, LP
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06194305 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 17 Years, studying Tourette Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06194305 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06194305 currently recruiting?
Yes, NCT06194305 is actively recruiting participants. Contact the research team at ticlab@umn.edu for enrollment information.
Where is the NCT06194305 trial being conducted?
This trial is being conducted at San Diego, United States, Minneapolis, United States.
Who is sponsoring the NCT06194305 clinical trial?
NCT06194305 is sponsored by University of Minnesota. The principal investigator is Christine Conelea, PhD, LP at University of Minnesota. The trial plans to enroll 100 participants.