Clinical Evaluation of HRV Biofeedback in Functional Neurological Disorders Compared to Placebo
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.
Centre hospitalier de l'Université de Montréal (CHUM)
31 participants
Sep 9, 2024
INTERVENTIONAL
Conditions
Summary
Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo.
Eligibility
Inclusion Criteria7
- 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 Criteria7
- 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
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Interventions
Biofeedback (BFB), sometimes referred to as "biological feedback technique," is a non-invasive and non-pharmacological approach based on physiological recordings that provide real-time feedback enabling people to learn how to control their physiological processes, which are typically unconscious and beyond their control. HRV-BFB specifically targets heart rate variability (HRV), which can help regulate the autonomic nervous system (including vagal tone and sympathetic-parasympathetic balance) as well as emotional states. HRV-BFB has been clinically and experimentally validated as a physiological intervention and has demonstrated its effectiveness. However, it has never been studied in an adult FND population.
The pseudo HRV-BFB intervention aims to implement the same HRV BFB methods with no specific effect on HRV.
Locations(1)
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NCT06422819