Tourette SyndromeCoBRaNCT06873841
Cognitive-psychophysiological Treatment for Tics in Young People With Tourette's Syndrome With or Without Biofeedback
A study testing Cognitive psychophysiological and Cognitive psychophysiological and Biofeedback in people with Tourette Syndrome and Tics, run by Université du Québec a Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Tourette Syndrome, Tics, Tourette Syndrome in Adolescence
- What is being tested?
- Cognitive psychophysiological and Cognitive psychophysiological and Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have a diagnosis of TS or to experience bothersome tics;
- Be aged 14 to 21 years inclusive at the start of therapy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal, Hôpital Rivières-des-Prairies
Montreal, Quebec, H1E 1A4
Julie Leclerc, 514-323-7260 ext. 2190, leclerc.julie@uqam.ca
Audrey-Ann Lachance, 5143237260 ext. 2381, audrey-ann.lachance.cnmtl@ssss.gouv.qc.ca
About this study
Official title: Can the Cognitive-Psychophysiological Treatment of Tics be Optimized Through Biofeedback in Adolescents and Emerging Adults With Tourette Syndrome? - A Randomized Clinical Trial
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:
Read more
- 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.
- 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.
Read the detailed description
- The project explanations are in English for everyone's ease of understanding, but our study is conducted in French. *
- Conditions
- Tourette Syndrome, Tics, Tourette Syndrome in Adolescence
- Being tested
- Cognitive psychophysiological, Cognitive psychophysiological and Biofeedback
- Keywords
- CoPs, Biofeedback, cognitive-psychophysiological therapy, Tourette, Young adults, Tics, Treatment
- Medical subject headings
- Tourette Syndrome, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive psychophysiologicalBehavioural
Focus on the processes influencing thoughts and behaviors underlying tics.
Cognitive psychophysiological and BiofeedbackBehavioural
Biofeedback refers to visual exercises that help improve movement control.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-psychophysiological therapy (CoPs). | Active comparator | 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. Receives: Behavioral: Cognitive psychophysiological |
| Cognitive-psychophysiological therapy (CoPs) combined with biofeedback exercises. | Experimental | 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). Receives: Behavioral: Cognitive psychophysiological and Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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))
Secondary outcomes (13)
Conners
Psychosocial measures For ADHD symptoms, the Conners 3 (8-18 years) or Conners' Adult ADHD Rating Scales (CAARS)
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Brief Cannabis Consumption Questionnaire
To attest the consumption of cannabis.
Measured: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start15 Apr 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université du Québec a Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Ciusss de L'Est de l'Île de Montréal
- Responsible party
- Principal investigator, Julie Leclerc, Université du Québec a Montréal
- Investigators
- Julie Leclerc, Psychology, Principal investigator, Université du Québec à Montréal- UQAMMarc Lavoie, Psychology, Study chair, Université TÉLUQMarie-France Marin, Psychology, Study chair, Université du Québec à Montréal-UQAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873841
- Sponsor's protocol ID
- PJT-191682
- Acronym
- CoBRa
- Status last verified
- Jul 2025
- First submitted
- 21 Jan 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Cognitive-Psychophysiological Treatment of Tics be Optimized Through Biofeedback in Adolescents and Emerging Adults With Tourette Syndrome? - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06873841
- Acronym / sponsor ID
- CoBRa / PJT-191682
- Conditions
- Tourette Syndrome, Tics, Tourette Syndrome in Adolescence
- Keywords
- CoPs, Biofeedback, cognitive-psychophysiological therapy, Tourette, Young adults, Tics, Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Université du Québec a MontréalUniversity, hospital or other
- Collaborators
- Ciusss de L'Est de l'Île de Montréal
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Detailed description
- The project explanations are in English for everyone's ease of understanding, but our study is conducted in French. *
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-psychophysiological therapy (CoPs). | Active comparator | Behavioral: Cognitive psychophysiologicalSix 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. |
| Cognitive-psychophysiological therapy (CoPs) combined with biofeedback exercises. | Experimental | Behavioral: Cognitive psychophysiological and BiofeedbackAfter 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). |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Have a diagnosis of TS or to experience bothersome tics;
- Be aged 14 to 21 years inclusive at the start of therapy.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive psychophysiologicalFocus on the processes influencing thoughts and behaviors underlying tics. | Behavioural | Cognitive-psychophysiological therapy (CoPs). |
| Cognitive psychophysiological and BiofeedbackBiofeedback refers to visual exercises that help improve movement control. | Behavioural | Cognitive-psychophysiological therapy (CoPs) combined with biofeedback exercises. |
Primary outcome
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))
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).
13 secondary outcomes
Conners
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
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
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
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
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
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
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
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
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)
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
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
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Brief Cannabis Consumption Questionnaire
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Leclerc, Psychology principal investigator
Université du Québec à Montréal- UQAM
Marc Lavoie, Psychology study chair
Université TÉLUQ
Marie-France Marin, Psychology study chair
Université du Québec à Montréal-UQAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive psychophysiological and Cognitive psychophysiological and Biofeedback in people with Tourette Syndrome and Tics, run by Université du Québec a Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Leclerc, Psychology (1-514-987-3000 ext. 5267, leclerc.julie@uqam.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.