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

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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Neurological Disorder
• Intervention / Treatment: Other: Heart rate variability Biofeedback [HRV-BFB]; Other: Pseudo HRV-BFB

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.

• Study Type: Interventional
• Enrollment (Estimated): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jasmine Carlier, PhD student; Phone Number: (+33)680891913; Email: jasmine.carlier.chum@ssss.gouv.qc.ca
• Study Contact Backup: Name: Dang Khoa Nguyen, Pr; Phone Number: 28404 514-890-8000; Email: d.nguyen@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 0C1
      • Université de Montréal's affiliated Hospital Research Centre (CRCHUM)
      • Contact: Jasmine Carlier, MD; Phone Number: (+33)680891913; Email: jasmine.rachel.zoe.carlier@umontreal.ca
      • Contact: Dang Khoa Nguyen, Md, PhD, Pr; Phone Number: 28404 H2X 0C1; Email: d.nguyen@umontreal.ca
      • Principal Investigator: Dang Khoa Nguyen, Pr
      • Sub-Investigator: Pascal Hot, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Sufficiently fluent in French to understand study documents and instructions
• Consistency in performing repeated questionnaires
• Normal or corrected-to-normal visual acuity

Exclusion Criteria:

• 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
• Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis)
• Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole)
• Participants placing under judicial or administrative supervisions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group (HRV-BFB training); Participants assigned to the experimental group will undergo HRV Biofeedback training using the Inner Balance Coherence Plus® software. This software incorporates a Bluetooth plethysmograph ear sensor, which will transmit cardiac pulse data to the Inner Balance Coherence Plus smartphone app, where the EmWave Pro® Plus software will extract HRV in real-time. This software will display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). Fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the HRV-BFB intervention, participants will be instructed to maximize their HRV.	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.
Placebo Comparator: Placebo Control group (Pseudo HRV-BFB training); Participants assigned to the placebo group will undergo a pseudo HRV Biofeedback training using the same Inner Balance Coherence Plus® software and ear sensor. The software will similarly display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). To manage placebo effects, the same fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the placebo pseudo BFB training, participants will be instructed to no have specific effect on HRV.	Other: Pseudo HRV-BFB; The pseudo HRV-BFB intervention aims to implement the same HRV BFB methods with no specific effect on HRV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 (V1)
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.	Up to 40 days from V1 (V2)
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.	Up to 80 days from V1 (V3)
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.	Up to 180 days from V1 (V4)
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.	Up to 360 days from V1 (V5)
Clinician Clinical Global Impression Score	The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner & Targum, 2007). This scale includes 2 items.	Day 1 (V1)
Clinician Clinical Global Impression Score	The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner & Targum, 2007). This scale includes 2 items.	Up to 40 days from V1 (V2)
Clinician Clinical Global Impression Score	The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner & Targum, 2007). This scale includes 2 items.	Up to 80 days from V1 (V3)
Clinician Clinical Global Impression Score	The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner & Targum, 2007). This scale includes 2 items.	Up to 180 days from V1 (V4)
Clinician Clinical Global Impression Score	The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner & Targum, 2007). This scale includes 2 items.	Up to 360 days from V1 (V5)
Quality of life Score	The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.	Day 1 (V1)
Quality of life Score	The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.	Up to 40 days from V1 (V2)
Quality of life Score	The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.	Up to 80 days from V1 (V3)
Quality of life Score	The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.	Up to 180 days from V1 (V4)
Quality of life Score	The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.	Up to 360 days from V1 (V5)
Self-perception of Occupation Score	The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.	Day 1 (V1)
Self-perception of Occupation Score	The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.	Up to 40 days from V1 (V2)
Self-perception of Occupation Score	The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.	Up to 80 days from V1 (V3)
Self-perception of Occupation Score	The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.	Up to 180 days from V1 (V4)
Self-perception of Occupation Score	The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.	Up to 360 days from V1 (V5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 (V1)
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.	Up to 40 days from V1 (V2)
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.	Up to 80 days from V1 (V3)
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.	Up to 180 days from V1 (V4)
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.	Up to 360 days from V1 (V5)
Depressive symptoms score	The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer & Rouillon, 1989). This scale includes 20 items.	Day 1 (V1)
Depressive symptoms score	The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer & Rouillon, 1989). This scale includes 20 items.	Up to 40 days from V1 (V2)
Depressive symptoms score	The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer & Rouillon, 1989). This scale includes 20 items.	Up to 80 days from V1 (V3)
Depressive symptoms score	The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer & Rouillon, 1989). This scale includes 20 items.	Up to 180 days from V1 (V4)
Depressive symptoms score	The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer & Rouillon, 1989). This scale includes 20 items.	Up to 360 days from V1 (V5)
Trait anxiety score	The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer & Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items.	Day 1 (V1)
Trait anxiety score	The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer & Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items.	Up to 40 days from V1 (V2)
Trait anxiety score	The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer & Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items.	Up to 80 days from V1 (V3)
Trait anxiety score	The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer & Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items.	Up to 180 days from V1 (V4)
Trait anxiety score	The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer & Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items.	Up to 360 days from V1 (V5)
Quality of sleep measure	The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items.	Day 1 (V1)
Quality of sleep measure	The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items.	Up to 40 days from V1 (V2)
Quality of sleep measure	The quality of sleep measure will be measure using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items.	Up to 80 days from V1 (V3)
Quality of sleep measure	The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items.	Up to 180 days from V1 (V4)
Quality of sleep measure	The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items.	Up to 360 days from V1 (V5)
Dissociative Experiences	The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items.	Day 1 (V1)
Dissociative Experiences	The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items.	Up to 40 days from V1 (V2)
Dissociative Experiences	The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items.	Up to 80 days from V1 (V3)
Dissociative Experiences	The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items.	Up to 180 days from V1 (V4)
Dissociative Experiences	The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items.	Up to 360 days from V1 (V5)
Alexithymia score	Alexithymia score will be measured using the Toronto Alexithymia Scale (TAS-20; French version Loas, 1996). This scale includes 20 items.	Day 1 (V1)
Brief Illness Perception score	Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items.	Day 1 (V1)
Brief Illness Perception score	Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items.	Up to 40 days from V1 (V2)
Brief Illness Perception score	Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items.	Up to 80 days from V1 (V3)
Brief Illness Perception score	Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items.	Up to 180 days from V1 (V4)
Brief Illness Perception score	Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items.	Up to 360 days from V1 (V5)
Emotion Regulation Profile	The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items.	Day 1 (V1)
Emotion Regulation Profile	The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items.	Up to 40 days from V1 (V2)
Emotion Regulation Profile	The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items.	Up to 80 days from V1 (V3)
Emotion Regulation Profile	The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items.	Up to 180 days from V1 (V4)
Emotion Regulation Profile	The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items.	Up to 360 days from V1 (V5)
Childhood Trauma profile	The Childhood Trauma profile will be measured using the Childhood Trauma Questionnaire-Short Form (CTQ; Frenc version Paquette et al., 2004). This scale includes 28 items.	Day 1 (V1)
Positive Affect and Negative Affects	The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci & Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items.	Day 1 (V1) before the emotional induction task
Positive Affect and Negative Affects	The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci & Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items.	Day 1 (V1) after the emotional induction task
Positive Affect and Negative Affects	The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci & Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items.	Up to 40 days from V1 (V2) before the emotional re-exposure task
Positive Affect and Negative Affects	The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci & Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items.	Up to 40 days from V1 (V2) after the emotional re-exposure task
High Frequency [HF] (>0.15 Hz)	High Frequency (>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].	Day 1 (V1)
High Frequency [HF] (>0.15 Hz)	High Frequency (>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].	Up to 40 days from V1 (V2)
High Frequency [HF] (>0.15 Hz)	High Frequency (>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].	Up to 80 days from V1 (V3)
High Frequency [HF] (>0.15 Hz)	High Frequency (>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].	Up to 180 days from V1 (V4)
High Frequency [HF] (>0.15 Hz)	High Frequency (>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].	Up to 360 days from V1 (V5)
Root Mean Square of Successive Differences [RMSSD]	Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].	Day 1 (V1)
Root Mean Square of Successive Differences [RMSSD]	Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].	Up to 40 days from V1 (V2)
Root Mean Square of Successive Differences [RMSSD]	Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].	Up to 80 days from V1 (V3)
Root Mean Square of Successive Differences [RMSSD]	Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].	Up to 180 days from V1 (V4)
Root Mean Square of Successive Differences [RMSSD]	Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].	Up to 360 days from V1 (V5)
Skin conductance responses [SCR] frequency	Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).	Day 1 (V1)
Skin conductance responses [SCR] frequency	Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).	Up to 40 days from V1 (V2)
Skin conductance responses [SCR] frequency	Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).	Up to 80 days from V1 (V3)
Skin conductance responses [SCR] frequency	Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).	Up to 180 days from V1 (V4)
Skin conductance responses [SCR] frequency	Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).	Up to 360 days from V1 (V5)
Skin conductance responses [SCR] amplitude	Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).	Day 1 (V1)
Skin conductance responses [SCR] amplitude	Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).	Up to 40 days from V1 (V2)
Skin conductance responses [SCR] amplitude	Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).	Up to 80 days from V1 (V3)
Skin conductance responses [SCR] amplitude	Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).	Up to 180 days from V1 (V4)
Skin conductance responses [SCR] amplitude	Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).	Up to 360 days from V1 (V5)
Delta frequency (0-4Hz)	Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Day 1 (V1)
Delta frequency (0-4Hz)	Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Up to 40 days from V1 (V2)
Delta frequency (0-4Hz)	Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Up to 80 days from V1 (V3)
Theta frequency (4-7Hz)	Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Day 1 (V1)
Theta frequency (4-7Hz)	Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Up to 40 days from V1 (V2)
Theta frequency (4-7Hz)	Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Up to 80 days from V1 (V3)
Alpha frequency (8-12Hz)	Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Day 1 (V1)
Alpha frequency (8-12Hz)	Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Up to 40 days from V1 (V2)
Alpha frequency (8-12Hz)	Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Up to 80 days from V1 (V3)
Beta frequency (13-30Hz)	Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Day 1 (V1)
Beta frequency (13-30Hz)	Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Up to 40 days from V1 (V2)
Beta frequency (13-30Hz)	Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Up to 80 days from V1 (V3)
Gamma frequency (>30Hz)	Gamma frequency >30 Hertz band Gamma frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Day 1 (V1)
Gamma frequency (>30Hz)	Gamma frequency >30 Hertz band Gamma frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Up to 40 days from V1 (V2)
Gamma frequency (>30Hz)	Gamma frequency >30 Hertz band Gamma frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.	Up to 80 days from V1 (V3)

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Laboratoire de Psychologie et NeuroCognition
• Investigators: Principal Investigator: Dang Khoa Nguyen, Université de Montréal's affiliated hospital research centre

Publications and helpful links

General Publications

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
• Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
• Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
• Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017.
• Pick S, Anderson DG, Asadi-Pooya AA, Aybek S, Baslet G, Bloem BR, Bradley-Westguard A, Brown RJ, Carson AJ, Chalder T, Damianova M, David AS, Edwards MJ, Epstein SA, Espay AJ, Garcin B, Goldstein LH, Hallett M, Jankovic J, Joyce EM, Kanaan RA, Keynejad RC, Kozlowska K, LaFaver K, LaFrance WC Jr, Lang AE, Lehn A, Lidstone S, Maurer CW, Mildon B, Morgante F, Myers L, Nicholson C, Nielsen G, Perez DL, Popkirov S, Reuber M, Rommelfanger KS, Schwingenshuh P, Serranova T, Shotbolt P, Stebbins GT, Stone J, Tijssen MA, Tinazzi M, Nicholson TR. Outcome measurement in functional neurological disorder: a systematic review and recommendations. J Neurol Neurosurg Psychiatry. 2020 Jun;91(6):638-649. doi: 10.1136/jnnp-2019-322180. Epub 2020 Feb 28.
• Steinberg M, Rounsaville B, Cicchetti D. Detection of dissociative disorders in psychiatric patients by a screening instrument and a structured diagnostic interview. Am J Psychiatry. 1991 Aug;148(8):1050-4. doi: 10.1176/ajp.148.8.1050.
• Loas G, Otmani O, Verrier A, Fremaux D, Marchand MP. Factor analysis of the French version of the 20-Item Toronto Alexithymia Scale (TAS-20). Psychopathology. 1996;29(2):139-44. doi: 10.1159/000284983.
• Boucsein W, Fowles DC, Grimnes S, Ben-Shakhar G, roth WT, Dawson ME, Filion DL; Society for Psychophysiological Research Ad Hoc Committee on Electrodermal Measures. Publication recommendations for electrodermal measurements. Psychophysiology. 2012 Aug;49(8):1017-34. doi: 10.1111/j.1469-8986.2012.01384.x. Epub 2012 Jun 8.
• American Clinical Neurophysiology Society. Guideline 6: A proposal for standard montages to be used in clinical EEG. J Clin Neurophysiol. 2006 Apr;23(2):111-7. doi: 10.1097/00004691-200604000-00007. No abstract available.
• Lehrer P, Kaur K, Sharma A, Shah K, Huseby R, Bhavsar J, Sgobba P, Zhang Y. Heart Rate Variability Biofeedback Improves Emotional and Physical Health and Performance: A Systematic Review and Meta Analysis. Appl Psychophysiol Biofeedback. 2020 Sep;45(3):109-129. doi: 10.1007/s10484-020-09466-z. Erratum In: Appl Psychophysiol Biofeedback. 2021 Dec;46(4):389. doi: 10.1007/s10484-021-09526-y.

Helpful Links

• Radloff LS. The CES-D scale: a self report depression scale for research in the general population. App Psycho Meas 1977;1:384-401.
• Paul Lehrer. Protocol for Heart Rate Variability Biofeedback Training. DOI:10.5298/1081-5937-41.3.08
• Alain Leplège 2001. Le questionnaire MOS SF-36, manuel d'utilisation et guide d'interprétation des scores
• Kathi Baron 2006 A User's Manual for the Occupational Self Assessment (OSA) : (Version 2.2)
• C Demoulin 2017. Traduction en français du " Brief Illness Perceived Questionnaire " adapté aux patients lombalgiques et étude de ses qualités métrologiques. Doi : 10.1016/S1169-8330(16)30511-7
• Daniel Paquette 2004. Validation de la version française du CTQ et prévalence de l'histoire de maltraitance. DOI: 10.7202/008831ar

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Autonomic nervous system; Endophenotypes; Functional Neurological Disorder; Transdiagnostic approach; Emotional dysregulation; Biofeedback of Heart Rate Variability
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Somatoform Disorders; Histrionic Personality Disorder; Nervous System Diseases; Conversion Disorder; Hysteria
• Other Study ID Numbers: 2024-12156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No