Cognitive-psychophysiological Treatment for Tics in Young People With Tourette's Syndrome With or Without Biofeedback

NCT06873841 | Recruiting DMC

• 1 other identifier: PJT-191682
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).

• STAI

  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

  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

  Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).

Other Outcomes (5)

• SCID-5-RV130

  Only in T1 (pre-test) , up to 4 weeks ( first interview).

• BASC-3-SRP131

  Only in T1 (pre-test) , up to 4 weeks ( first interview).

• Bem Sex Role

  Only in T1 (pre-test) , up to 4 weeks ( first interview).

Study Arms (2)

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.

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).

Behavioral: Cognitive psychophysiological and Biofeedback

Interventions

Cognitive psychophysiological BEHAVIORAL

Focus on the processes influencing thoughts and behaviors underlying tics.

Cognitive-psychophysiological therapy (CoPs).

Cognitive psychophysiological and Biofeedback BEHAVIORAL

Biofeedback refers to visual exercises that help improve movement control.

Cognitive-psychophysiological therapy (CoPs) combined with biofeedback exercises.

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Have a diagnosis of TS or to experience bothersome tics;
• Be aged 14 to 21 years inclusive at the start of therapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université du Québec a Montréal: lead
• Ciusss de L'Est de l'Île de Montréal: collaborator

Study Sites (1)

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

Montreal, Quebec, H1E 1A4, Canada

RECRUITING

MeSH Terms

Conditions

Tourette Syndrome; Tics

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Julie Leclerc, Psychology

  Université du Québec à Montréal- UQAM

  PRINCIPAL INVESTIGATOR

• Marc Lavoie, Psychology

  Université TÉLUQ

  STUDY CHAIR

• Marie-France Marin, Psychology

  Université du Québec à Montréal-UQAM

  STUDY CHAIR

Central Study Contacts

Julie Leclerc, Psychology

CONTACT

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

Audrey-Ann Lachance

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization ensures that participants will not immediately know their treatment modality. However, since we do not have a drug under study and the interventions are therapies, the participant may end up knowing their group by themselves. To avoid biases, the evaluators will have no idea which group the participant belongs to. Only the therapists will know the participants' modality, as they are the ones who will administer it.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor, psychology department, UQAM. Researcher & Mental Health Research Director, Centre intégré universitaire santé et services sociaux (CIUSSS) Nord-de-l'Île-de-Montréal. Associate Researcher, Institut Universitaire Santé Mentale de Montreal

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: March 13, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)