Can the Cognitive-Psychophysiological Treatment of Tics be Optimized Through Biofeedback in Adolescents and Emerging Adults With Tourette Syndrome? - A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to compare the effectiveness of CoPs therapy with or without the therapeutic component of biofeedback in treating tics in Tourette Syndrome with emerging young adults. Hypotheses: 1. The CoPs+Biofeedback treatment will improve the severity of tics (YGTSS) and the Clinical Global Impression, surpassing the clinical significance threshold of CoPs treatment alone. 2. We expect that the identified variables (psychosocial, neurocognitive, biological) will predict the improvement of tics. Researchers will compare if the biofeedback treatment will improve the severity of tics. * In the pre-test, participants will undergo two interviews, each lasting 3 hours. These interviews will assess (through a battery of tests) the severity of tics as well as the psychosocial, biological, and neurocognitive aspects of functioning. A general assessment of intelligence and executive functions will also be conducted. * They will next attend 10 to 12 therapy sessions, with or without biofeedback. (The biofeedback component is explained in more detail in the ''Study Design'' section). * The post-test follow-ups consist of two evaluations: one 3 months after the end of the treatment and the other 6 months after. The evaluation will be done using the same battery of tests as during the pre-test interview.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 21
Healthy Volunteers: f
View:

• Have a diagnosis of TS or to experience bothersome tics;

• Be aged 14 to 21 years inclusive at the start of therapy.

Locations
Other Locations
Canada
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal, Hôpital Rivières-des-Prairies
RECRUITING
Montreal
Contact Information
Primary
Julie Leclerc, Psychology
leclerc.julie@uqam.ca
1-514-987-3000
Backup
Audrey-Ann Lachance
audrey-ann.lachance.cnmtl@ssss.gouv.qc.ca
1-514-323-7260
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2029-12
Participants
Target number of participants: 150
Treatments
Active_comparator: Cognitive-psychophysiological therapy (CoPs).
Six therapeutic steps: 1) Awareness training; 2) Profile of high/low-risk situations for tics; 3) Muscular discrimination; 4) Reduction of sensorimotor activation and modification of action planning style; 5) Cognitive, metacognitive, and behavioral restructuring in high-risk tic situations; 6) Generalization and relapse prevention.~The individual sessions last 80 minutes: 55 minutes of therapy, 20 minutes of active listening and 5 minutes for a computer activity. The active listening and activity are unrelated to the analyses but ensure that treatment modalities are equivalent in duration and use of a computer. Participants will be informed about the duration of the therapy (10 to 12 sessions weekly) and that its completion requires continuous attendance at the sessions. The program has been adapted for youth with a treatment guide containing examples and exercises tailored for better understanding. Adolescents aged 14 to 17 will receive this manual to support their comprehension.
Experimental: Cognitive-psychophysiological therapy (CoPs) combined with biofeedback exercises.
After each 55-minute CoPs session (same protocol as arm 1), 25 minutes will be dedicated to biofeedback exercises (80 minutes total). This 25-minute period includes 2 minutes to record the baseline resting level, 15 minutes for the active biofeedback session, and 2 minutes for the second resting measurement.~Active electromyographic (EMG) biofeedback will take the form of computer-generated graphs displayed on a screen at 2 meters (horizontal angle). Changes in muscle activity will cause the movement of a balance with a silvered ball; the graphical feedback of this stimulus is particularly effective in capturing the participant's attention and interactive engagement. The goal is to contract the arm muscle to keep the ball balanced for 5 minutes for each arm, then 5 minutes with both arms (15 minutes).
Sponsors
Collaborators: Ciusss de L'Est de l'Île de Montréal
Leads: Université du Québec a Montréal

This content was sourced from clinicaltrials.gov