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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Heart rate variability Biofeedback [HRV-BFB]

    Other intervention

    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.

  • Pseudo HRV-BFB

    Other intervention

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

Treatment groups

31 Participants
are divided into 2 treatment groups
Group A: Experimental group (HRV-BFB training)Experimental treatment 1 intervention
Group B: Placebo Control group (Pseudo HRV-BFB training)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient Clinical Global Impression Score

The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items.

Time frame
Day 1 (V1)
2

Patient Clinical Global Impression Score

The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items.

Time frame
Up to 40 days from V1 (V2)
3

Patient Clinical Global Impression Score

The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items.

Time frame
Up to 80 days from V1 (V3)
4

Patient Clinical Global Impression Score

The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items.

Time frame
Up to 180 days from V1 (V4)

Secondary outcomes

1

Other physical symptoms score

The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items.

Time frame
Day 1 (V1)
2

Other physical symptoms score

The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items.

Time frame
Up to 40 days from V1 (V2)
3

Other physical symptoms score

The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items.

Time frame
Up to 80 days from V1 (V3)
4

Other physical symptoms score

The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items.

Time frame
Up to 180 days from V1 (V4)

Other outcomes

Sponsors and contacts

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Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Laboratoire de Psychologie et NeuroCognition

Collaborator