Cognitive Psychophysiological Therapy + Biofeedback for Tourette Syndrome

(CoBRa Trial)

Recruiting at 2 trial locations

Overseen By Audrey-Ann Lachance

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Université du Québec a Montréal

Disqualifiers: Sensorimotor impairment, Intellectual disability, Alcohol or drug abuse, Neurological issue, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 10-12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a therapy for young adults with Tourette Syndrome (TS) to determine if adding biofeedback—a technique using visual or auditory feedback to control body functions—enhances its effectiveness in reducing tics. Participants will attend cognitive psychophysiological therapy sessions, with or without biofeedback exercises, to assess which method better alleviates tic severity. Individuals aged 14 to 21 with a TS diagnosis or bothersome tics may be suitable for this trial. Participants must not have certain conditions, such as sensorimotor impairments or recent substance abuse. As an unphased trial, this study provides a unique opportunity to explore innovative treatment combinations for TS.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you must inform the research team if you change your medication one month before starting and during the trial.

What prior data suggests that this therapy and biofeedback method is safe for treating tics in Tourette Syndrome?

Research has shown that cognitive psychophysiological therapy (CoPs) for tics in Tourette Syndrome has been used without specific safety concerns reported in studies. This therapy helps individuals become more aware of their tics and manage situations that might trigger them.

Regarding the therapy combined with biofeedback, specific safety data is not available. However, biofeedback is generally considered low-risk. It uses technology to help individuals control certain body functions, like muscle tension.

This clinical trial is labeled as "Not Applicable" in terms of phase, indicating that the treatment is already in use or not considered high-risk. Treatments at this stage are usually well-tolerated with minimal risk of serious side effects. Participants can expect the trial to focus more on the treatment's effectiveness rather than safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Psychophysiological Therapy (CoPs) with and without biofeedback for Tourette Syndrome because it offers a novel approach compared to traditional treatments like medications and behavioral therapy. CoPs focuses on enhancing awareness and control over tics through cognitive and metacognitive techniques, which is different from standard therapies that primarily target tic suppression. The addition of biofeedback provides real-time feedback on muscle activity, encouraging participants to actively engage and self-regulate their tics. This interactive component could lead to better long-term management of symptoms by empowering individuals to gain more control over their condition.

What evidence suggests that this trial's treatments could be effective for Tourette Syndrome?

Research has shown that cognitive psychophysiological therapy (CoPs), a treatment in this trial, can reduce tic severity and improve overall functioning in people with Tourette syndrome. Studies have found that this approach significantly improves tic symptoms. Another treatment arm in this trial combines CoPs therapy with biofeedback, which might enhance these benefits. Biofeedback increases awareness and control of body functions, potentially leading to better results in reducing tics. Early findings suggest that combining CoPs with biofeedback might be more effective than using CoPs therapy alone for treating tics. ^{1 5 6 7 8}

Who Is on the Research Team?

Julie Leclerc, Psychology

Principal Investigator

Université du Québec à Montréal- UQAM

Marc Lavoie, Psychology

Principal Investigator

Université TÉLUQ

Marie-France Marin, Psychology

Principal Investigator

Université du Québec à Montréal-UQAM

Are You a Good Fit for This Trial?

This trial is for young people aged 14-21 with Tourette's Syndrome (TS) as their main issue. Participants must not have sensorimotor impairments, intellectual disability (IQ below 75), substance abuse problems, other neurological issues, or be changing medications or receiving other tic interventions during the study without notifying researchers.

Inclusion Criteria

I am between 14 and 21 years old.

Have a diagnosis of TS as the main issue, as reported by the participant

Exclusion Criteria

Have a diagnosis of intellectual disability (intelligence quotient below 75)

Alcohol or drug abuse

I am not seeing another professional for my tics without telling the research team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

2 visits (in-person)

Pre-test

Participants undergo two interviews to assess the severity of tics and other psychosocial, biological, and neurocognitive aspects

Up to 4 weeks

2 visits (in-person)

Treatment

Participants attend 10 to 12 therapy sessions with or without biofeedback

10-12 weeks

10-12 visits (in-person)

Post-test Follow-up

Participants are evaluated using the same battery of tests as during the pre-test interview

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive psychophysiological
• Cognitive psychophysiological and Biofeedback

Trial Overview The trial aims to see if Cognitive-psychophysiological Therapy (CoPs) combined with Biofeedback is more effective than CoPs alone in reducing tics in Tourette Syndrome. It involves pre-test assessments, 10-12 therapy sessions with or without biofeedback, and follow-up evaluations at 3 and 6 months post-treatment using a battery of tests.

How Is the Trial Designed?

Group I: Cognitive-psychophysiological therapy (CoPs) combined with biofeedback exercises. Experimental Treatment 1 Intervention

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 II: Cognitive-psychophysiological therapy (CoPs). Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Université du Québec a Montréal

Lead Sponsor

Trials

28

Recruited

5,600+

Ciusss de L'Est de l'Île de Montréal

Collaborator

Trials

81

Recruited

6,400+

CIUSSS du Nord-de-l'Île-de-Montréal

Collaborator

Trials

4

Recruited

820+

Published Research Related to This Trial

Neurofeedback shows promise as a therapeutic option for improving executive control functions in individuals with Gilles-de-la-Tourette syndrome (GTS), particularly when ADHD symptoms are present, as these deficits may be linked to underlying brain circuit dysfunctions.

Despite the potential benefits, research on the use of neurofeedback for cognitive dysfunctions in GTS is limited, highlighting the need for further studies to explore its effectiveness and integration into treatment strategies for comorbid GTS and ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback and its possible relevance for the treatment of Tourette syndrome. Farkas, A., Bluschke, A., Roessner, V., et al.[2022]

Habit reversal training (HRT) is the most supported behavioral intervention for treating tic disorders in children and adolescents, based on a systematic review of 12 reviews and 8 randomized controlled trials.

Exposure with response prevention (ERP) is also effective and recommended as a first-line treatment, while other methods like neurofeedback remain experimental and psychosocial interventions lack sufficient research support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European clinical guidelines for Tourette syndrome and other tic disorders. Part III: behavioural and psychosocial interventions. Verdellen, C., van de Griendt, J., Hartmann, A., et al.[2022]

A new randomized controlled trial is being set up to test a neurofeedback intervention for Tourette Syndrome and chronic tic disorder, building on promising results from a previous small study with 21 adolescents.

The intervention uses fMRI to help participants learn to control activity in the supplementary motor area of the brain, with a focus on transparency in the study design to aid future neurofeedback research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol description for a randomized controlled trial of fMRI neurofeedback for tics in adolescents with Tourette Syndrome. Awasthi, J., Harris-Starling, C., Kalvin, C., et al.[2023]

In a randomized controlled trial involving 21 patients with Tourette syndrome, electrodermal biofeedback training did not show a significant advantage over sham feedback in reducing tic frequency or improving well-being after 4 weeks of treatment.

The study suggests that the short duration of training sessions may have limited the effectiveness of biofeedback, indicating that further research is needed to optimize training schedules for potential benefits in managing tics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial. Nagai, Y., Cavanna, AE., Critchley, HD., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S258997912400009X

Comparison of cognitive-behavioral treatments for tics and ... In conclusion, CoPs and CBIT effectively reduce tic severity and improve global functioning in children and adults with tic disorders and Tourette syndrome.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03225430

Evaluation of a Cognitive Psychophysiological Treatment ... The hypotheses are that: (1) the CoPs group will show superiority in clinically significant improvement on standard tic scale score, global functioning and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5669407/

Behavioral therapy for Tourette syndrome and chronic tic ... MP led to a significant reduction of tics (30%), but was overall less effective than HRT (97%). Based on these data, MP appears to have only limited therapeutic ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2016.00135/full

The Effect of a New Therapy for Children with Tics ... This study applied a manualized treatment for childhood tics disorder, Facotik, to a consecutive case series of children aged 8–12 years.

5. trialx.com trialx.com/clinical-trials/listings/300024/cognitive-psychophysiological-treatment-for-tics-in-young-people-with-tourettes-syndrome-with-or-without-biofeedback/

Cognitive-psychophysiological Treatment for Tics in Young ... The goal of this clinical trial is to compare the effectiveness of CoPs therapy with or without the therapeutic component of biofeedback in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06873841

Cognitive-psychophysiological Treatment for Tics in Young ... Active Comparator : Cognitive-psychophysiological therapy (CoPs). Six therapeutic steps: 1) Awareness training; 2) Profile of high/low-risk situations for tics; ...

7. withpower.com withpower.com/trial/phase-tourette-syndrome-2-2025-aca29

Cognitive Psychophysiological Therapy + Biofeedback for ... The research articles reviewed do not provide specific safety data for Cognitive Psychophysiological Therapy + Biofeedback, but neurofeedback, a related ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26250742/

Evaluation of a cognitive psychophysiological model for ... The current study reports an open trial evaluating the effectiveness of a cognitive psychophysiological treatment addressing Tourette-specific sensorimotor ...