Evaluating Heart Rate Variability Biofeedback for Functional Neurological Disorders
Probing the Heart Rate Variability Biofeedback as an Innovative and Non-invasive Treatment for Functional Neurological Disorders Guided by a Multimodal Approach of Autonomic Nervous System.
This study tests if Heart Rate Variability Biofeedback can help people with Functional Neurological Disorders feel better compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06422819 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical effects of Heart Rate Variability Biofeedback (HRV-BFB) in patients with Functional Neurological Disorders (FND) compared to a placebo. It aims to explore the relationship between emotional dysregulation and autonomic nervous system profiles in FND patients. Participants will undergo a comprehensive clinical evaluation and complete emotional tasks while their autonomic responses are measured. The study employs a single-blind crossover design to assess the varying responses to HRV-BFB based on individual autonomic profiles.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Functional Neurological Disorders who are fluent in French and can use a smartphone.
Not a fit: Patients with severe psychiatric conditions, significant autonomic dysfunctions, or those requiring specialized medical attention may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to personalized therapies that improve the management of Functional Neurological Disorders.
How similar studies have performed: While HRV-BFB has shown promise in other populations, this specific application in adults with Functional Neurological Disorders is novel and has not been previously assessed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Functional Neurological Disorders (FND) diagnosis must be medically established * Participants must have a smartphone (android ou Iphone) * Participants must be of the age of majority * Participants must have signed an informed consent * Sufficiently fluent in French to understand study documents and instructions * Consistency in performing repeated questionnaires * Normal or corrected-to-normal visual acuity Exclusion Criteria: * Specially protected participants: juveniles, pregnant womens, nursing mothers, law's protection peoples * Participants suffering from a severe psychiatric disease needing specialised attention * History of severe neurosurgical pathology * Alcohol dependence or drug use * Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis) * Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole) * Participants placing under judicial or administrative supervisions
Where this trial is running
Montreal, Quebec
- Université de Montréal's affiliated Hospital Research Centre (CRCHUM) — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Dang Khoa Nguyen — Université de Montréal's affiliated hospital research centre
- Study coordinator: Jasmine Carlier, PhD student
- Email: jasmine.carlier.chum@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.