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NCT Number: NCT06422819

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

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

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Key information

Conditions

Functional Neurological Disorder Conversion Disorder Mental Disorders Somatoform Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Montréal's affiliated Hospital Research Centre (CRCHUM)

Montreal, Quebec, H2X 0C1, Canada

Location status: Recruiting

Location contact

Dang Khoa Nguyen, Md, PhD, Pr

CONTACT

[email protected]

H2X 0C1 ext. 28404

Dang Khoa Nguyen, Pr

PRINCIPAL_INVESTIGATOR

Jasmine Carlier, MD

CONTACT

[email protected]

(+33)680891913

Pascal Hot, Pr

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart rate variability Biofeedback [HRV-BFB]

Other

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

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

Primary outcomes

  1. Patient Clinical Global Impression Score

    Time frame: Day 1 (V1)

    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.

  2. Patient Clinical Global Impression Score

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

    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.

  3. Patient Clinical Global Impression Score

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

    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.

  4. Patient Clinical Global Impression Score

    Time frame: Up to 180 days from V1 (V4)

    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.

  5. Patient Clinical Global Impression Score

    Time frame: Up to 360 days from V1 (V5)

    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.

  6. Clinician Clinical Global Impression Score

    Time frame: Day 1 (V1)

    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.

  7. Clinician Clinical Global Impression Score

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

    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.

  8. Clinician Clinical Global Impression Score

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

    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.

  9. Clinician Clinical Global Impression Score

    Time frame: Up to 180 days from V1 (V4)

    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.

  10. Clinician Clinical Global Impression Score

    Time frame: Up to 360 days from V1 (V5)

    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.

  11. Quality of life Score

    Time frame: Day 1 (V1)

    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.

  12. Quality of life Score

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

    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.

  13. Quality of life Score

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

    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.

  14. Quality of life Score

    Time frame: Up to 180 days from V1 (V4)

    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.

  15. Quality of life Score

    Time frame: Up to 360 days from V1 (V5)

    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.

  16. Self-perception of Occupation Score

    Time frame: Day 1 (V1)

    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.

  17. Self-perception of Occupation Score

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

    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.

  18. Self-perception of Occupation Score

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

    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.

  19. Self-perception of Occupation Score

    Time frame: Up to 180 days from V1 (V4)

    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.

  20. Self-perception of Occupation Score

    Time frame: Up to 360 days from V1 (V5)

    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.

Secondary outcomes

  1. Other physical symptoms score

    Time frame: Day 1 (V1)

    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.

  2. Other physical symptoms score

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

    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.

  3. Other physical symptoms score

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

    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.

  4. Other physical symptoms score

    Time frame: Up to 180 days from V1 (V4)

    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.

  5. Other physical symptoms score

    Time frame: Up to 360 days from V1 (V5)

    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.

  6. Depressive symptoms score

    Time frame: Day 1 (V1)

    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.

  7. Depressive symptoms score

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

    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.

  8. Depressive symptoms score

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

    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.

  9. Depressive symptoms score

    Time frame: Up to 180 days from V1 (V4)

    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.

  10. Depressive symptoms score

    Time frame: Up to 360 days from V1 (V5)

    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.

  11. Trait anxiety score

    Time frame: Day 1 (V1)

    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.

  12. Trait anxiety score

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

    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.

  13. Trait anxiety score

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

    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.

  14. Trait anxiety score

    Time frame: Up to 180 days from V1 (V4)

    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.

  15. Trait anxiety score

    Time frame: Up to 360 days from V1 (V5)

    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.

  16. Quality of sleep measure

    Time frame: Day 1 (V1)

    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.

  17. Quality of sleep measure

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

    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.

  18. Quality of sleep measure

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

    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.

  19. Quality of sleep measure

    Time frame: Up to 180 days from V1 (V4)

    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.

  20. Quality of sleep measure

    Time frame: Up to 360 days from V1 (V5)

    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.

  21. Dissociative Experiences

    Time frame: Day 1 (V1)

    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.

  22. Dissociative Experiences

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

    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.

  23. Dissociative Experiences

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

    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.

  24. Dissociative Experiences

    Time frame: Up to 180 days from V1 (V4)

    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.

  25. Dissociative Experiences

    Time frame: Up to 360 days from V1 (V5)

    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.

  26. Alexithymia score

    Time frame: Day 1 (V1)

    Alexithymia score will be measured using the Toronto Alexithymia Scale (TAS-20; French version Loas, 1996). This scale includes 20 items.

  27. Brief Illness Perception score

    Time frame: Day 1 (V1)

    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.

  28. Brief Illness Perception score

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

    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.

  29. Brief Illness Perception score

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

    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.

  30. Brief Illness Perception score

    Time frame: Up to 180 days from V1 (V4)

    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.

  31. Brief Illness Perception score

    Time frame: Up to 360 days from V1 (V5)

    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.

  32. Emotion Regulation Profile

    Time frame: Day 1 (V1)

    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.

  33. Emotion Regulation Profile

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

    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.

  34. Emotion Regulation Profile

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

    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.

  35. Emotion Regulation Profile

    Time frame: Up to 180 days from V1 (V4)

    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.

  36. Emotion Regulation Profile

    Time frame: Up to 360 days from V1 (V5)

    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.

  37. Childhood Trauma profile

    Time frame: Day 1 (V1)

    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.

  38. Positive Affect and Negative Affects

    Time frame: Day 1 (V1) before the emotional induction task

    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.

  39. Positive Affect and Negative Affects

    Time frame: Day 1 (V1) after the emotional induction task

    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.

  40. Positive Affect and Negative Affects

    Time frame: Up to 40 days from V1 (V2) before the emotional re-exposure task

    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.

  41. Positive Affect and Negative Affects

    Time frame: Up to 40 days from V1 (V2) after the emotional re-exposure task

    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.

  42. High Frequency [HF] (>0.15 Hz)

    Time frame: Day 1 (V1)

    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].

  43. High Frequency [HF] (>0.15 Hz)

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

    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].

  44. High Frequency [HF] (>0.15 Hz)

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

    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].

  45. High Frequency [HF] (>0.15 Hz)

    Time frame: Up to 180 days from V1 (V4)

    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].

  46. High Frequency [HF] (>0.15 Hz)

    Time frame: Up to 360 days from V1 (V5)

    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].

  47. Root Mean Square of Successive Differences [RMSSD]

    Time frame: Day 1 (V1)

    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].

  48. Root Mean Square of Successive Differences [RMSSD]

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

    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].

  49. Root Mean Square of Successive Differences [RMSSD]

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

    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].

  50. Root Mean Square of Successive Differences [RMSSD]

    Time frame: Up to 180 days from V1 (V4)

    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].

  51. Root Mean Square of Successive Differences [RMSSD]

    Time frame: Up to 360 days from V1 (V5)

    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].

  52. Skin conductance responses [SCR] frequency

    Time frame: Day 1 (V1)

    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).

  53. Skin conductance responses [SCR] frequency

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

    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).

  54. Skin conductance responses [SCR] frequency

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

    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).

  55. Skin conductance responses [SCR] frequency

    Time frame: Up to 180 days from V1 (V4)

    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).

  56. Skin conductance responses [SCR] frequency

    Time frame: Up to 360 days from V1 (V5)

    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).

  57. Skin conductance responses [SCR] amplitude

    Time frame: Day 1 (V1)

    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).

  58. Skin conductance responses [SCR] amplitude

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

    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).

  59. Skin conductance responses [SCR] amplitude

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

    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).

  60. Skin conductance responses [SCR] amplitude

    Time frame: Up to 180 days from V1 (V4)

    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).

  61. Skin conductance responses [SCR] amplitude

    Time frame: Up to 360 days from V1 (V5)

    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).

  62. Delta frequency (0-4Hz)

    Time frame: Day 1 (V1)

    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.

  63. Delta frequency (0-4Hz)

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

    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.

  64. Delta frequency (0-4Hz)

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

    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.

  65. Theta frequency (4-7Hz)

    Time frame: Day 1 (V1)

    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.

  66. Theta frequency (4-7Hz)

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

    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.

  67. Theta frequency (4-7Hz)

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

    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.

  68. Alpha frequency (8-12Hz)

    Time frame: Day 1 (V1)

    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.

  69. Alpha frequency (8-12Hz)

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

    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.

  70. Alpha frequency (8-12Hz)

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

    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.

  71. Beta frequency (13-30Hz)

    Time frame: Day 1 (V1)

    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.

  72. Beta frequency (13-30Hz)

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

    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.

  73. Beta frequency (13-30Hz)

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

    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.

  74. Gamma frequency (>30Hz)

    Time frame: Day 1 (V1)

    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.

  75. Gamma frequency (>30Hz)

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

    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.

  76. Gamma frequency (>30Hz)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dang Khoa Nguyen, Pr

CONTACT

[email protected]

514-890-8000 ext. 28404

Jasmine Carlier, PhD student

CONTACT

[email protected]

514-890-8000 ext. 28404

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Laboratoire de Psychologie et NeuroCognition

Registry information

Official study 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.

Acronym: HRV_BFB_FND

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 21, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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