HRV Biofeedback for Functional Neurological Disorder
(HRV_BFB_FND Trial)
Trial Summary
What is the purpose of this trial?
Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo.
Will I have to stop taking my current medications?
If you are taking medications that affect the autonomic nervous system, like certain heart or depression medications, you may need to stop them to join this trial.
What data supports the effectiveness of the treatment HRV Biofeedback for Functional Neurological Disorder?
Research shows that HRV biofeedback can improve heart rate variability and reduce symptoms related to the autonomic nervous system (which controls involuntary actions like heartbeat) in stroke patients. It has also been shown to enhance emotional regulation and problem-solving in people with brain injuries, suggesting it may help with similar issues in Functional Neurological Disorder.12345
Is HRV Biofeedback safe for humans?
How is HRV Biofeedback treatment different from other treatments for Functional Neurological Disorder?
HRV Biofeedback is unique because it helps patients learn to control their heart rate variability through real-time feedback, which can improve autonomic nervous system function and emotional regulation. Unlike other treatments, it focuses on self-regulation and enhancing parasympathetic activity, which may not be addressed by standard therapies.12569
Research Team
Dang Khoa Nguyen
Principal Investigator
Université de Montréal's affiliated hospital research centre
Eligibility Criteria
This trial is for individuals with Functional Neurological Disorders, which can include symptoms like uncontrolled movements or blackouts without a clear physical cause. Participants should be diagnosed with conditions such as Conversion Disorder or similar nervous system disorders.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Comprehensive clinical evaluation including symptoms, functional capacity, quality of life, and assessment of physical and psychological comorbidities
Treatment
Participants undergo HRV Biofeedback training or placebo training using Inner Balance Coherence Plus® software for 30 days
Crossover Treatment
Participants switch to the alternate intervention (HRV-BFB or placebo) for another 30 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including repeated measures of symptoms, functional capacity, and quality of life
Treatment Details
Interventions
- HRV Biofeedback
HRV Biofeedback is already approved in United States, European Union for the following indications:
- Anxiety disorders
- Depression
- Hypertension
- Temporomandibular joint (TMJ) syndrome
- Urinary incontinence
- Fecal incontinence
- Irritable bowel syndrome
- Migraine and tension headaches
- Anxiety disorders
- Depression
- Hypertension
- Temporomandibular joint (TMJ) syndrome
- Urinary incontinence
- Fecal incontinence
- Irritable bowel syndrome
- Migraine and tension headaches
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Laboratoire de Psychologie et NeuroCognition
Collaborator