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.

What this Trial Is About

Researchers are evaluating the effects of Heart Rate Variability Biofeedback (HRV-BFB) training in adults with Functional Neurological Disorders (FND). FND is a common neurological condition with unclear causes, possibly involving disrupted emotional processes and autonomic nervous system dysfunction. This study aims to understand these mechanisms and assess how HRV-BFB compares to a placebo treatment using a single-blind crossover design. Participants will be randomly assigned to either the HRV-BFB group or a placebo group. Both groups will use the Inner Balance Coherence Plus® software with a Bluetooth ear sensor and smartphone app. Training sessions last 8 minutes, twice daily for 30 days, with different breathing instructions depending on the group. The HRV-BFB group will work to increase their heart rate variability, while the placebo group will receive similar sessions without specific HRV effects. Throughout the study, participants will undergo comprehensive evaluations including symptoms, functional capacity, quality of life, and psychological assessments. These will be measured multiple times up to 360 days after starting. Emotional tasks and autonomic measures will also be repeated. Researchers will track heart rate variability and other physical and psychological outcomes to understand the effects of the training and identify patient subgroups based on autonomic profiles.

Clinical Evaluation of HRV Biofeedback in Functional Neurological Disorders Compared to Placebo