Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422819
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
Clinical Evaluation of HRV Biofeedback in Functional Neurological Disorders Compared to Placebo
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HRV_BFB_FND
Brief Summary:
Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None