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

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.

Overview

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

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.

Interventions

• Other Heart rate variability Biofeedback [HRV-BFB]
  Biofeedback (BFB), sometimes referred to as "biological feedback technique," is a non-invasive and non-pharmacological approach based on physiological recordings that provide real-time feedback enabling people to learn how to control their physiological processes, which are typically unconscious and beyond their control. HRV-BFB specifically targets heart rate variability (HRV), which can help regulate the autonomic nervous system (including vagal tone and sympathetic-parasympathetic balance) as
• Other Pseudo HRV-BFB
  The pseudo HRV-BFB intervention aims to implement the same HRV BFB methods with no specific effect on HRV.

Primary outcome measures

• Patient Clinical Global Impression Score [Time frame: Day 1 (V1)]
• Patient Clinical Global Impression Score [Time frame: Up to 40 days from V1 (V2)]
• Patient Clinical Global Impression Score [Time frame: Up to 80 days from V1 (V3)]
• Patient Clinical Global Impression Score [Time frame: Up to 180 days from V1 (V4)]
• Patient Clinical Global Impression Score [Time frame: Up to 360 days from V1 (V5)]
• Clinician Clinical Global Impression Score [Time frame: Day 1 (V1)]
• Clinician Clinical Global Impression Score [Time frame: Up to 40 days from V1 (V2)]
• Clinician Clinical Global Impression Score [Time frame: Up to 80 days from V1 (V3)]
• Clinician Clinical Global Impression Score [Time frame: Up to 180 days from V1 (V4)]
• Clinician Clinical Global Impression Score [Time frame: Up to 360 days from V1 (V5)]

Secondary outcome measures (12)

• Other physical symptoms score [Time frame: Day 1 (V1)]
• Other physical symptoms score [Time frame: Up to 40 days from V1 (V2)]
• Other physical symptoms score [Time frame: Up to 80 days from V1 (V3)]
• Other physical symptoms score [Time frame: Up to 180 days from V1 (V4)]
• Other physical symptoms score [Time frame: Up to 360 days from V1 (V5)]
• Depressive symptoms score [Time frame: Day 1 (V1)]
• Depressive symptoms score [Time frame: Up to 40 days from V1 (V2)]
• Depressive symptoms score [Time frame: Up to 80 days from V1 (V3)]
• Depressive symptoms score [Time frame: Up to 180 days from V1 (V4)]
• Depressive symptoms score [Time frame: Up to 360 days from V1 (V5)]
• Trait anxiety score [Time frame: Day 1 (V1)]
• Trait anxiety score [Time frame: Up to 40 days from V1 (V2)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Supportive care

Study locations

Canada · 1 center

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

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. PMID 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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 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. PMID 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. PMID 1853955

Identifiers

NCT: NCT06422819 · 2024-12156

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗