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

Functional Neurological Disorder Clinical Trial

— HRV_BFB_FND  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422819
• Other study ID #: 2024-12156
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Jasmine Carlier, PhD student
• Phone: (+33)680891913
• Email: jasmine.carlier.chum[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 31
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Neurological Disorder
• Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Université de Montréal's affiliated Hospital Research Centre (CRCHUM)	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Laboratoire de Psychologie et NeuroCognition

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. — View Citation

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( — View Citation

Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37. — View Citation

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. — View Citation

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 abs — View Citation

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. — View Citation

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. eC — View Citation

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):10 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Alain Leplège 2001. Le questionnaire MOS SF-36, manuel d'utilisation et guide d'interprétation des scores
•   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
•   Kathi Baron 2006 A User's Manual for the Occupational Self Assessment (OSA) : (Version 2.2)
•   Paul Lehrer. Protocol for Heart Rate Variability Biofeedback Training. DOI:10.5298/1081-5937-41.3.08
•   Radloff LS. The CES-D scale: a self report depression scale for research in the general population. App Psycho Meas 1977;1:384-401.