AzTrials
AzTrials

Functional Neurological DisorderHRV_BFB_FNDNCT06422819

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

A study testing Heart rate variability Biofeedback [HRV-BFB] and Pseudo HRV-BFB in people with Functional Neurological Disorder, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Functional Neurological Disorder
What is being tested?
Heart rate variability Biofeedback [HRV-BFB] and Pseudo HRV-BFB
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteCanada
Study dates
9 Sep 2024to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

    Montreal, Quebec, H2X 0C1

Other trials in Canada

About this study

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.

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

Read the 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.

Being tested
Heart rate variability Biofeedback [HRV-BFB], Pseudo HRV-BFB
Keywords
Functional Neurological Disorder, Emotional dysregulation, Autonomic nervous system, Endophenotypes, Biofeedback of Heart Rate Variability, Transdiagnostic approach
Medical subject headings
Conversion Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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-BFBOther

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

Study groups in NCT06422819
Study groupRoleWhat they receive
Experimental group (HRV-BFB training)ExperimentalParticipants 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.
Receives: Other: Heart rate variability Biofeedback [HRV-BFB]
Placebo Control group (Pseudo HRV-BFB training)Placebo comparatorParticipants 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.
Receives: Other: Pseudo HRV-BFB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Clinical Global Impression Score

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

    Measured: Day 1 (V1)

  2. Patient Clinical Global Impression Score

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

    Measured: Up to 40 days from V1 (V2)

  3. Patient Clinical Global Impression Score

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

    Measured: Up to 80 days from V1 (V3)

  4. Patient Clinical Global Impression Score

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

    Measured: Up to 180 days from V1 (V4)

  5. 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.

    Measured: Up to 360 days from V1 (V5)

  6. 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.

    Measured: Day 1 (V1)

  7. 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.

    Measured: Up to 40 days from V1 (V2)

  8. 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.

    Measured: Up to 80 days from V1 (V3)

  9. 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.

    Measured: Up to 180 days from V1 (V4)

  10. 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.

    Measured: Up to 360 days from V1 (V5)

  11. 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.

    Measured: Day 1 (V1)

  12. 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.

    Measured: Up to 40 days from V1 (V2)

  13. 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.

    Measured: Up to 80 days from V1 (V3)

  14. 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.

    Measured: Up to 180 days from V1 (V4)

  15. 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.

    Measured: Up to 360 days from V1 (V5)

  16. 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.

    Measured: Day 1 (V1)

  17. 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.

    Measured: Up to 40 days from V1 (V2)

  18. 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.

    Measured: Up to 80 days from V1 (V3)

  19. 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.

    Measured: Up to 180 days from V1 (V4)

  20. 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.

    Measured: Up to 360 days from V1 (V5)

Secondary outcomes (76)

  1. Other physical symptoms score

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

    Measured: Day 1 (V1)

  2. Other physical symptoms score

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

    Measured: Up to 40 days from V1 (V2)

  3. Other physical symptoms score

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

    Measured: Up to 80 days from V1 (V3)

  4. Other physical symptoms score

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

    Measured: Up to 180 days from V1 (V4)

  5. 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.

    Measured: Up to 360 days from V1 (V5)

  6. 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.

    Measured: Day 1 (V1)

  7. 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.

    Measured: Up to 40 days from V1 (V2)

  8. 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.

    Measured: Up to 80 days from V1 (V3)

  9. 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.

    Measured: Up to 180 days from V1 (V4)

  10. 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.

    Measured: Up to 360 days from V1 (V5)

  11. 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.

    Measured: Day 1 (V1)

  12. 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.

    Measured: Up to 40 days from V1 (V2)

  13. 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.

    Measured: Up to 80 days from V1 (V3)

  14. 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.

    Measured: Up to 180 days from V1 (V4)

  15. 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.

    Measured: Up to 360 days from V1 (V5)

  16. 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.

    Measured: Day 1 (V1)

  17. 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.

    Measured: Up to 40 days from V1 (V2)

  18. 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.

    Measured: Up to 80 days from V1 (V3)

  19. 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.

    Measured: Up to 180 days from V1 (V4)

  20. 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.

    Measured: Up to 360 days from V1 (V5)

  21. 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.

    Measured: Day 1 (V1)

  22. 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.

    Measured: Up to 40 days from V1 (V2)

  23. 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.

    Measured: Up to 80 days from V1 (V3)

  24. 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.

    Measured: Up to 180 days from V1 (V4)

  25. 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.

    Measured: Up to 360 days from V1 (V5)

  26. Alexithymia score

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

    Measured: Day 1 (V1)

  27. 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.

    Measured: Day 1 (V1)

  28. 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.

    Measured: Up to 40 days from V1 (V2)

  29. 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.

    Measured: Up to 80 days from V1 (V3)

  30. 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.

    Measured: Up to 180 days from V1 (V4)

  31. 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.

    Measured: Up to 360 days from V1 (V5)

  32. 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.

    Measured: Day 1 (V1)

  33. 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.

    Measured: Up to 40 days from V1 (V2)

  34. 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.

    Measured: Up to 80 days from V1 (V3)

  35. 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.

    Measured: Up to 180 days from V1 (V4)

  36. 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.

    Measured: Up to 360 days from V1 (V5)

  37. 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.

    Measured: Day 1 (V1)

  38. 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.

    Measured: Day 1 (V1) before the emotional induction task

  39. 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.

    Measured: Day 1 (V1) after the emotional induction task

  40. 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.

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

  41. 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.

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

  42. 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].

    Measured: Day 1 (V1)

  43. 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].

    Measured: Up to 40 days from V1 (V2)

  44. 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].

    Measured: Up to 80 days from V1 (V3)

  45. 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].

    Measured: Up to 180 days from V1 (V4)

  46. 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].

    Measured: Up to 360 days from V1 (V5)

  47. 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].

    Measured: Day 1 (V1)

  48. 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].

    Measured: Up to 40 days from V1 (V2)

  49. 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].

    Measured: Up to 80 days from V1 (V3)

  50. 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].

    Measured: Up to 180 days from V1 (V4)

  51. 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].

    Measured: Up to 360 days from V1 (V5)

  52. 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).

    Measured: Day 1 (V1)

  53. 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).

    Measured: Up to 40 days from V1 (V2)

  54. 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).

    Measured: Up to 80 days from V1 (V3)

  55. 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).

    Measured: Up to 180 days from V1 (V4)

  56. 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).

    Measured: Up to 360 days from V1 (V5)

  57. 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).

    Measured: Day 1 (V1)

  58. 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).

    Measured: Up to 40 days from V1 (V2)

  59. 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).

    Measured: Up to 80 days from V1 (V3)

  60. 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).

    Measured: Up to 180 days from V1 (V4)

  61. 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).

    Measured: Up to 360 days from V1 (V5)

  62. 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.

    Measured: Day 1 (V1)

  63. 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.

    Measured: Up to 40 days from V1 (V2)

  64. 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.

    Measured: Up to 80 days from V1 (V3)

  65. 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.

    Measured: Day 1 (V1)

  66. 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.

    Measured: Up to 40 days from V1 (V2)

  67. 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.

    Measured: Up to 80 days from V1 (V3)

  68. 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.

    Measured: Day 1 (V1)

  69. 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.

    Measured: Up to 40 days from V1 (V2)

  70. 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.

    Measured: Up to 80 days from V1 (V3)

  71. 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.

    Measured: Day 1 (V1)

  72. 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.

    Measured: Up to 40 days from V1 (V2)

  73. 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.

    Measured: Up to 80 days from V1 (V3)

  74. 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.

    Measured: Day 1 (V1)

  75. 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.

    Measured: Up to 40 days from V1 (V2)

  76. 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.

    Measured: Up to 80 days from V1 (V3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2024
  2. Study start9 Sep 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
This study consists of 5 visits (V1, V2, V3, V4, V5). At V1, participants will be randomized into two groups: HRV-BFB (experimental group) or Pseudo HRV-BFB (control group). Participants will remain single-blinded after randomization. Depending on the assigned group, participants will practice one specific intervention during the first 30-day period (V1-V2). At V2, participants will switch to the other arm and practice the second intervention during the second 30-day period (V2-V3). At V3, both interventions will end, and participants will be unblinded and encouraged to continue HRV-BFB at home. Clinical evaluation will be repeated 5 times at day 1 (V1), days 30 +/- 10 (V2), days 60 +/- 10 (V2), 6 months (V4) and 1 year (V5). The research team will exercise extreme caution to ensure consistent instructions and feedback, minimizing biases associated with lack of double-blinding.
Masking
Single blind
Who is masked
Participant
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06422819
Sponsor's protocol ID
2024-12156
Acronym
HRV_BFB_FND
Status last verified
Mar 2026
First submitted
15 May 2024
Last updated
14 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 8598068

  • 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.

    PubMed 32385728

  • 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.

    PubMed 28265249

  • 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.

    PubMed 32111637

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

    PubMed 20526405

  • 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.

    PubMed 11914441

  • 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.

    PubMed 2748771

  • 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.

    PubMed 1853955

  • 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.

    PubMed 8861519

  • 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.

    PubMed 3397865

  • 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.

    PubMed 22680988

  • 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.

    PubMed 16612227

Questions about this trial

What is this clinical trial studying?

A study testing Heart rate variability Biofeedback [HRV-BFB] and Pseudo HRV-BFB in people with Functional Neurological Disorder, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Clinical Global Impression Score (time frame: Day 1 (V1)). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06422819, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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