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

Université du Québec a Montréal

Status: Enrolling

Conditions: Tourette Syndrome; Tourette Syndrome in Adolescence; Tics

Treatments: Behavioral: Cognitive psychophysiological; Behavioral: Cognitive psychophysiological and Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT06873841

PJT-191682

Details and patient eligibility

About

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.

Full description

* The project explanations are in English for everyone's ease of understanding, but our study is conducted in French. *

Enrollment: 150 estimated patients

Sex: All

Ages: 14 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Cognitive-psychophysiological therapy (CoPs).

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive psychophysiological

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

Experimental group

Description:

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).

Treatment:

Behavioral: Cognitive psychophysiological and Biofeedback