Clinical Evaluation of HRV Biofeedback in Functional Neurological

Status Not yet recruiting

Clinical Trial Summary

Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo.

Clinical Trial Description

Although Functional Neurological Disorders (FND) represent one of the most common reasons for consultation in Neurology, the pathological mechanisms remain unexplained. Recent studies suggest disrupted emotional processes in patients with FND and disturbed autonomic nervous system profiles, highligting the hypothesis of autonomic endophenotypes among the FND population. The Heart Rate Variability Biofeedback (HRV-BFB) is an innovative and non-invasive approach, based on the self-regulation of autonomic physiological processes. It has shown promising results in clinical and non-clinical populations but has never been assessed in an adult FND population. Therefore, this approach appears particularly promising for understanding the mechanisms underlying FND and developing personalized therapy. The main objective is to investigate the clinical effects of HRV-BFB on FND patients compared to placebo in a single-blind crossover design. The investigators predict that depending on their autonomic profile, patients will respond to HRV-BFB to varying degrees. Firstly, patients with FND will prospectively undergo an comprehensive clinical evaluation considering symptoms, functional capacity, quality of life, and an assessment of the physical and psychological comorbidities. Then patients will complete an emotional task and undergo multimodal autonomic measures. Cluster analyses will be conducted to identify both dysfunctional and functional autonomic profiles associated with the clinical exploration, enabling confirmation of the endophenotypes hypothesis and allowing for specific characterization of the profils. The clinical evaluation of the beneficial effects of HRV BFB will rely on repeated mesures of symptoms, functional capacity, and quality of life at scheduled points in time before and after the both interventions (HRV-BFB and pseudo-BFB). The emotional task and autonomic measures will be repeated simultaneously. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06422819
Study type	Interventional
Source	Centre hospitalier de l'Université de Montréal (CHUM)
Contact	Jasmine Carlier, PhD student
Phone	(+33)680891913
Email	jasmine.carlier.chum@ssss.gouv.qc.ca
Status	Not yet recruiting
Phase	N/A
Start date	June 2024
Completion date	May 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms