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

NCT06422819 | Recruiting

• 1 other identifier: 2024-12156
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Neurological Disorder

Keywords

Functional Neurological Disorder; Emotional dysregulation; Autonomic nervous system; Endophenotypes; Biofeedback of Heart Rate Variability; Transdiagnostic approach

Outcome Measures

Primary Outcomes (20)

• Patient Clinical Global Impression Score

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

  Day 1 (V1)

• Patient Clinical Global Impression Score

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

  Up to 40 days from V1 (V2)

• Patient Clinical Global Impression Score

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

  Up to 80 days from V1 (V3)

• Patient Clinical Global Impression Score

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

  Up to 180 days from V1 (V4)

• Patient Clinical Global Impression Score

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

  Up to 360 days from V1 (V5)

• Clinician Clinical Global Impression Score

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

  Day 1 (V1)

• Clinician Clinical Global Impression Score

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

  Up to 40 days from V1 (V2)

• Clinician Clinical Global Impression Score

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

  Up to 80 days from V1 (V3)

• Clinician Clinical Global Impression Score

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

  Up to 180 days from V1 (V4)

• Clinician Clinical Global Impression Score

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

  Up to 360 days from V1 (V5)

• Quality of life Score

  The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.

  Day 1 (V1)

• Quality of life Score

  The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.

  Up to 40 days from V1 (V2)

• Quality of life Score

  The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.

  Up to 80 days from V1 (V3)

• Quality of life Score

  The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.

  Up to 180 days from V1 (V4)

• Quality of life Score

  The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.

  Up to 360 days from V1 (V5)

• Self-perception of Occupation Score

  The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.

  Day 1 (V1)

• Self-perception of Occupation Score

  The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.

  Up to 40 days from V1 (V2)

• Self-perception of Occupation Score

  The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.

  Up to 80 days from V1 (V3)

• Self-perception of Occupation Score

  The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.

  Up to 180 days from V1 (V4)

• Self-perception of Occupation Score

  The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.

  Up to 360 days from V1 (V5)

Secondary Outcomes (76)

• Other physical symptoms score

  Day 1 (V1)

• Other physical symptoms score

  Up to 40 days from V1 (V2)

• Other physical symptoms score

  Up to 80 days from V1 (V3)

• Other physical symptoms score

  Up to 180 days from V1 (V4)

• Other physical symptoms score

  Up to 360 days from V1 (V5)

Study Arms (2)

Experimental group (HRV-BFB training)

EXPERIMENTAL

Participants assigned to the experimental group will undergo HRV Biofeedback training using the Inner Balance Coherence Plus® software. This software incorporates a Bluetooth plethysmograph ear sensor, which will transmit cardiac pulse data to the Inner Balance Coherence Plus smartphone app, where the EmWave Pro® Plus software will extract HRV in real-time. This software will display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). Fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the HRV-BFB intervention, participants will be instructed to maximize their HRV.

Other: Heart rate variability Biofeedback [HRV-BFB]

Placebo Control group (Pseudo HRV-BFB training)

PLACEBO COMPARATOR

Participants assigned to the placebo group will undergo a pseudo HRV Biofeedback training using the same Inner Balance Coherence Plus® software and ear sensor. The software will similarly display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). To manage placebo effects, the same fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the placebo pseudo BFB training, participants will be instructed to no have specific effect on HRV.

Other: Pseudo HRV-BFB

Interventions

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.

Experimental group (HRV-BFB training)

Pseudo HRV-BFB OTHER

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

Placebo Control group (Pseudo HRV-BFB training)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Laboratoire de Psychologie et NeuroCognition: collaborator

Study Sites (1)

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

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Related Publications (12)

• 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.

  PMID: 8598068 RESULT

• 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.

  PMID: 32385728 RESULT

• 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.

  PMID: 28265249 RESULT

• 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.

  PMID: 32111637 RESULT

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

  PMID: 20526405 RESULT

• 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.

  PMID: 11914441 RESULT

• 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.

  PMID: 2748771 RESULT

• 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.

  PMID: 1853955 RESULT

• 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.

  PMID: 8861519 RESULT

• 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.

  PMID: 3397865 RESULT

• 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.

  PMID: 22680988 RESULT

• 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.

  PMID: 16612227 RESULT

Related Links

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

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Dang Khoa Nguyen

  Université de Montréal's affiliated hospital research centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmine Carlier, PhD student

CONTACT

514-890-8000; jasmine.carlier.chum@ssss.gouv.qc.ca

Dang Khoa Nguyen, Pr

CONTACT

514-890-8000; d.nguyen@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants won't be informed of the condition to which they belong. A debriefing will be done at the end of the last intervention (V3) for each participant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)