Cognitive Psychophysiological Therapy + Biofeedback for Tourette Syndrome

(CoBRa Trial)

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?

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.

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.

Is Cognitive Psychophysiological Therapy + Biofeedback safe for humans?

The research articles reviewed do not provide specific safety data for Cognitive Psychophysiological Therapy + Biofeedback, but neurofeedback, a related technique, is generally considered safe and has been used in various neuropsychiatric disorders, including Tourette Syndrome. ^{1 2 3 4 5}

How does the treatment Cognitive Psychophysiological Therapy + Biofeedback for Tourette Syndrome differ from other treatments?

This treatment is unique because it combines cognitive psychophysiological therapy, which focuses on changing brain activity through psychological interventions, with biofeedback, a technique that helps patients gain control over physiological functions. This approach targets both the cognitive and physiological aspects of Tourette Syndrome, potentially offering benefits for those who do not respond well to standard treatments. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Cognitive Psychophysiological Therapy + Biofeedback for Tourette Syndrome?

Research suggests that biofeedback and cognitive behavioral therapy, which are components of the treatment, can help reduce tics in Tourette syndrome. Studies have shown that these therapies can improve brain activity and executive control functions, leading to better management of symptoms. ^{1 2 3 5 7}

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

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

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

Alcohol or drug abuse

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

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Bridging neuroscience and clinical psychology: cognitive behavioral and psychophysiological models in the evaluation and treatment of Gilles de la Tourette syndrome. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Neurofeedback and its possible relevance for the treatment of Tourette syndrome. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Infra-low frequency neurofeedback in application to Tourette syndrome and other tic disorders: A clinical case series. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

European clinical guidelines for Tourette syndrome and other tic disorders. Part III: behavioural and psychosocial interventions. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Protocol description for a randomized controlled trial of fMRI neurofeedback for tics in adolescents with Tourette Syndrome. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Electrophysiology Echoes Brain Dynamics in Children and Adolescents With Tourette Syndrome-A Developmental Perspective. [2021]