Cognitive-psychophysiological therapy, with or without biofeedback, for tics in young people with Tourette's
Can the Cognitive-Psychophysiological Treatment of Tics be Optimized Through Biofeedback in Adolescents and Emerging Adults With Tourette Syndrome? - A Randomized Clinical Trial
NA · Université du Québec a Montréal · NCT06873841
This project tests whether adding biofeedback to cognitive-psychophysiological therapy helps reduce tics in 14–21-year-olds with Tourette's.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 14 Years to 21 Years |
| Sex | All |
| Sponsor | Université du Québec a Montréal (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06873841 on ClinicalTrials.gov |
What this trial studies
Participants complete two pre-treatment interviews totaling about six hours that measure tic severity (including the YGTSS), psychosocial, neurocognitive, and biological variables, plus general intelligence and executive function. They then receive 10 to 12 sessions of cognitive-psychophysiological therapy either with or without a biofeedback component. Outcomes include tic severity and Clinical Global Impression scores, measured through the planned follow-up visits. The protocol is delivered in French at a Montreal clinical site, with project explanations available in English.
Who should consider this trial
Good fit: Ideal candidates are 14–21-year-olds with Tourette's or bothersome tics who can attend in-person visits at the Montreal site and do not have intellectual disability, significant sensorimotor impairment, active substance abuse, or major neurological disease.
Not a fit: Patients with IQ below 75, sensorimotor impairments, active alcohol or drug abuse, major neurological disorders, or those who cannot avoid other simultaneous tic treatments or recent medication changes may not benefit or be eligible.
Why it matters
Potential benefit: If successful, adding biofeedback could produce greater tic reduction and improved overall clinical functioning compared with the therapy alone.
How similar studies have performed: Behavioral approaches for tics (e.g., habit reversal/CBIT) have shown benefit, but combining cognitive-psychophysiological therapy with biofeedback is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a diagnosis of TS or to experience bothersome tics; * Be aged 14 to 21 years inclusive at the start of therapy. Exclusion Criteria: * Present a sensorimotor impairment; * Have a diagnosis of intellectual disability (intelligence quotient below 75); * Alcohol or drug abuse; * A neurological issue (e.g., hemifacial spasms, Huntington's disease); * Change medication one month or less before step 1 and up to step 4 (last measurement time) without informing a member of the research team; * Simultaneously receive another intervention for tics (e.g., psychologist, massage therapist) without informing a research team member.
Where this trial is running
Montreal, Quebec
- Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal, Hôpital Rivières-des-Prairies — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Julie Leclerc, Psychology — Université du Québec à Montréal- UQAM
- Study coordinator: Julie Leclerc, Psychology
- Email: leclerc.julie@uqam.ca
- Phone: 1-514-987-3000
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.
Conditions: Tourette Syndrome, Tics, Tourette Syndrome in Adolescence, CoPs, Biofeedback, cognitive-psychophysiological therapy, Tourette, Young adults