Recruiting

CoPs & Biofeedback

Sponsor:

Université du Québec a Montréal

Code:

NCT06873841

Conditions

Tourette Syndrome

Tics

Tourette Syndrome in Adolescence

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Not accepted

Interventions

Cognitive psychophysiological

Cognitive psychophysiological and Biofeedback

Study Details

Brief 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.

Conditions

Tourette Syndrome

Tics

Tourette Syndrome in Adolescence

Study ID

NCT06873841

Start date

Apr 15, 2025

Status verified date

Jul, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

Cognitive psychophysiological

Focus on the processes influencing thoughts and behaviors underlying tics.

Cognitive psychophysiological and Biofeedback

Biofeedback refers to visual exercises that help improve movement control.

Primary outcome measure

  • Primary outcome [ Time Frame: The YGTSS is administered trough the study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)) ]

Central Contacts and Locations

Central contacts

Julie Leclerc, Psychology

1-514-987-3000leclerc.julie@uqam.ca

Audrey-Ann Lachance

1-514-323-7260audrey-ann.lachance.cnmtl@ssss.gouv.qc.ca

Locations

Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal, Hôpital Rivières-des-Prairies

Recruiting

Montreal, Quebec, Canada, H1E 1A4

Contacts

Julie Leclerc

514-323-7260leclerc.julie@uqam.ca

Audrey-Ann Lachance

5143237260audrey-ann.lachance.cnmtl@ssss.gouv.qc.ca

Principal Investigator:

Julie Leclerc

More Information

Sponsor

Université du Québec a Montréal

Last update posted

Jul 8, 2025

Last verified

Jul, 2025

Keywords

  • CoPs
  • Biofeedback
  • cognitive-psychophysiological therapy
  • Tourette
  • Young adults
  • Tics
  • Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université du Québec a Montréal on 2025-07-08.