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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
Heart rate variability Biofeedback [HRV-BFB]
Other interventionBiofeedback (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 interventionThe pseudo HRV-BFB intervention aims to implement the same HRV BFB methods with no specific effect on HRV.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Laboratoire de Psychologie et NeuroCognition
Collaborator