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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of Neurofeedback as an Adjunctive Treatment for Youth in Outpatient Mental Health Settings

NCT04871009

Trauma

COMPLETED NA

The Effectiveness of Group Guided Written Exposure Therapy for CPTSD Symptoms Among Adolescents

NCT06931093

CPTSD, Compelx Post-traumatic Stress Disorder

RECRUITING NA

Sensory Processing in Tourette Syndrome

NCT02512406

Tourette Syndrome

COMPLETED

Combination of Active or Placebo Attentional Bias Modification Treatment (ABMT) to Either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for Anxiety Disorders in Children

NCT01687764

Generalized Anxiety Disorder Separation Anxiety Disorder Social Anxiety Disorder

UNKNOWN NA

Anger Control Training for Youth With Tourette Syndrome

NCT00486551

Tourette Syndrome Chronic Tic Disorder Oppositional Defiant Disorder +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tourette Syndrome Tics Tourette Syndrome in Adolescence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Cognitive psychophysiological

Intervention Type BEHAVIORAL

Focus on the processes influencing thoughts and behaviors underlying tics.

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).

Group Type EXPERIMENTAL

Cognitive psychophysiological and Biofeedback

Intervention Type BEHAVIORAL

Biofeedback refers to visual exercises that help improve movement control.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive psychophysiological

Focus on the processes influencing thoughts and behaviors underlying tics.

Intervention Type BEHAVIORAL

Cognitive psychophysiological and Biofeedback

Biofeedback refers to visual exercises that help improve movement control.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Julie Leclerc

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

Responsibility Role PRINCIPAL_INVESTIGATOR