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

NCT06422819 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-09-19

No results posted yet for this study

Summary

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

Conditions

  • Functional Neurological Disorder

Interventions

OTHER

Heart rate variability Biofeedback [HRV-BFB]

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.

OTHER

Pseudo HRV-BFB

The pseudo HRV-BFB intervention aims to implement the same HRV BFB methods with no specific effect on HRV.

Sponsors & Collaborators

  • Laboratoire de Psychologie et NeuroCognition

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Dang Khoa Nguyen · Université de Montréal's affiliated hospital research centre

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06422819 on ClinicalTrials.gov