An interventional study of Cognitive psychophysiological and Cognitive psychophysiological and Biofeedback in Tourette Syndrome, Tics and Tourette Syndrome in Adolescence, sponsored by Université du Québec a Montréal. Recruiting at 1 site in Canada. Open to participants aged 14 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Université du Québec a Montréal · Not applicable, Interventional, and Treatment
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:
Researchers will compare if the biofeedback treatment will improve the severity of tics.
* The project explanations are in English for everyone's ease of understanding, but our study is conducted in French. *
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's planned enrollment of 150 is above the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Université du Québec a Montréal is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Cognitive psychophysiological
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).
Behavioral: Cognitive psychophysiological and Biofeedback
Focus on the processes influencing thoughts and behaviors underlying tics.
Biofeedback refers to visual exercises that help improve movement control.
Primary outcome
The Yale Global Tic Severity Scale (YGTSS) provides an assessment of motor and vocal tics based on 5 dimensions: number, frequency, intensity, complexity, and interference. A subtotal of 50 is used to determine the severity of the tics. A separate scale assesses impairment, or the overall effect of tic disorders on daily functioning, with another subtotal of 50. In this study, only the tic severity score out of 50 will be used (comparable to other studies focusing on tics).
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))
Conners
Psychosocial measures For ADHD symptoms, the Conners 3 (8-18 years) or Conners' Adult ADHD Rating Scales (CAARS)
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
CY-BOCS
For OCD symptoms, the Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
STAI
For anxiety symptoms, the State-Trait Anxiety Inventory (STAI).
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
Perfectionism Scale
The adapted/inadapted Perfectionism Scale
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
Beck Depression Invetory
For mood-related symptoms, the Beck Depression Inventory will be used.
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
STOP
The Style of Planning Action (STOP)
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
Self-Esteem Inventory
The short version of the Self-Esteem Inventory.
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
TS-Quality of Life Scale
TS-Quality of Life Scale will also be used.
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
Perdue Pegboard Test
The evaluation of fine motor dexterity using the Purdue Pegboard will determine the baseline equivalence between groups and test functional differences after treatment. The Finger-Tapping Test will be administered to assess speed and motor control.
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
Perceived Stress Scale (PSS-14)
We will collect a hair sample to measure the cortisol levels of the participants: a 14-item Perceived Stress Scale (PSS-14) will be administered at the 4 time points of measurement.
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
Finger-Tapping Test
The Finger-Tapping Test will be administered to assess speed and motor control.
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
DKEFS CWIT
Participants will be assessed with the 4 sections of the DKEFS CWIT: color naming, word reading, inhibition.
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Brief Cannabis Consumption Questionnaire
To attest the consumption of cannabis.
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
SCID-5-RV130
The Structured Clinical Interview for DSM-5 - Research (SCID-5-RV130) will allow for clinical screening of disorders that may present a differential or comorbid diagnosis with PTSD, which could impact treatment engagement or outcomes.
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
BASC-3-SRP131
The Behavioral Assessment System, 3rd Edition - Self-Report of Personality (BASC-3-SRP131) will be administered to provide an overall profile of affect and behavior, complementing the SCID-5-RV.
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Bem Sex Role
Sex assigned at birth and gender identity will be assessed using the Bem Sex Role Inventory.
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Wechsler
General intelligence will be evaluated through subscales of the Wechsler Intelligence Scale for Children/Adults, depending on the participant's age (WAIS-IV, WISC-V: Vocabulary, Matrices).
Time frame: Only in T1 (pre-test) , up to 4 weeks (first interview).
BRIEF
Executive functions will also be screened using the Brief Inventory of Executive Function (BRIEF), (version for ages 14-18 years or adults).
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Plan to share: No
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Université du Québec a Montréal