Clinical trial NCT06422819: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Neurological Disorder
Keywords: Functional Neurological Disorder
Emotional dysregulation
Autonomic nervous system
Endophenotypes
Biofeedback of Heart Rate Variability
Transdiagnostic approach
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Laboratoire de Psychologie et NeuroCognition
First posted: 2024-05-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Patient Clinical Global Impression Score
timeFrame: Day 1 (V1)
measure: Patient Clinical Global Impression Score
timeFrame: Up to 40 days from V1 (V2)
measure: Patient Clinical Global Impression Score
timeFrame: Up to 80 days from V1 (V3)
measure: Patient Clinical Global Impression Score
timeFrame: Up to 180 days from V1 (V4)
measure: Patient Clinical Global Impression Score
timeFrame: Up to 360 days from V1 (V5)
measure: Clinician Clinical Global Impression Score
timeFrame: Day 1 (V1)
measure: Clinician Clinical Global Impression Score
timeFrame: Up to 40 days from V1 (V2)
measure: Clinician Clinical Global Impression Score
timeFrame: Up to 80 days from V1 (V3)
measure: Clinician Clinical Global Impression Score
timeFrame: Up to 180 days from V1 (V4)
measure: Clinician Clinical Global Impression Score
timeFrame: Up to 360 days from V1 (V5)
measure: Quality of life Score
timeFrame: Day 1 (V1)
measure: Quality of life Score
timeFrame: Up to 40 days from V1 (V2)
measure: Quality of life Score
timeFrame: Up to 80 days from V1 (V3)
measure: Quality of life Score
timeFrame: Up to 180 days from V1 (V4)
measure: Quality of life Score
timeFrame: Up to 360 days from V1 (V5)
measure: Self-perception of Occupation Score
timeFrame: Day 1 (V1)
measure: Self-perception of Occupation Score
timeFrame: Up to 40 days from V1 (V2)
measure: Self-perception of Occupation Score
timeFrame: Up to 80 days from V1 (V3)
measure: Self-perception of Occupation Score
timeFrame: Up to 180 days from V1 (V4)
measure: Self-perception of Occupation Score
timeFrame: Up to 360 days from V1 (V5)
Secondary outcomes:
measure: Other physical symptoms score
timeFrame: Day 1 (V1)
measure: Other physical symptoms score
timeFrame: Up to 40 days from V1 (V2)
measure: Other physical symptoms score
timeFrame: Up to 80 days from V1 (V3)
measure: Other physical symptoms score
timeFrame: Up to 180 days from V1 (V4)
measure: Other physical symptoms score
timeFrame: Up to 360 days from V1 (V5)
measure: Depressive symptoms score
timeFrame: Day 1 (V1)
measure: Depressive symptoms score
timeFrame: Up to 40 days from V1 (V2)
measure: Depressive symptoms score
timeFrame: Up to 80 days from V1 (V3)
measure: Depressive symptoms score
timeFrame: Up to 180 days from V1 (V4)
measure: Depressive symptoms score
timeFrame: Up to 360 days from V1 (V5)
measure: Trait anxiety score
timeFrame: Day 1 (V1)
measure: Trait anxiety score
timeFrame: Up to 40 days from V1 (V2)
measure: Trait anxiety score
timeFrame: Up to 80 days from V1 (V3)
measure: Trait anxiety score
timeFrame: Up to 180 days from V1 (V4)
measure: Trait anxiety score
timeFrame: Up to 360 days from V1 (V5)
measure: Quality of sleep measure
timeFrame: Day 1 (V1)
measure: Quality of sleep measure
timeFrame: Up to 40 days from V1 (V2)
measure: Quality of sleep measure
timeFrame: Up to 80 days from V1 (V3)
measure: Quality of sleep measure
timeFrame: Up to 180 days from V1 (V4)
measure: Quality of sleep measure
timeFrame: Up to 360 days from V1 (V5)
measure: Dissociative Experiences
timeFrame: Day 1 (V1)
measure: Dissociative Experiences
timeFrame: Up to 40 days from V1 (V2)
measure: Dissociative Experiences
timeFrame: Up to 80 days from V1 (V3)
measure: Dissociative Experiences
timeFrame: Up to 180 days from V1 (V4)
measure: Dissociative Experiences
timeFrame: Up to 360 days from V1 (V5)
measure: Alexithymia score
timeFrame: Day 1 (V1)
measure: Brief Illness Perception score
timeFrame: Day 1 (V1)
measure: Brief Illness Perception score
timeFrame: Up to 40 days from V1 (V2)
measure: Brief Illness Perception score
timeFrame: Up to 80 days from V1 (V3)
measure: Brief Illness Perception score
timeFrame: Up to 180 days from V1 (V4)
measure: Brief Illness Perception score
timeFrame: Up to 360 days from V1 (V5)
measure: Emotion Regulation Profile
timeFrame: Day 1 (V1)
measure: Emotion Regulation Profile
timeFrame: Up to 40 days from V1 (V2)
measure: Emotion Regulation Profile
timeFrame: Up to 80 days from V1 (V3)
measure: Emotion Regulation Profile
timeFrame: Up to 180 days from V1 (V4)
measure: Emotion Regulation Profile
timeFrame: Up to 360 days from V1 (V5)
measure: Childhood Trauma profile
timeFrame: Day 1 (V1)
measure: Positive Affect and Negative Affects
timeFrame: Day 1 (V1) before the emotional induction task
measure: Positive Affect and Negative Affects
timeFrame: Day 1 (V1) after the emotional induction task
measure: Positive Affect and Negative Affects
timeFrame: Up to 40 days from V1 (V2) before the emotional re-exposure task
measure: Positive Affect and Negative Affects
timeFrame: Up to 40 days from V1 (V2) after the emotional re-exposure task
measure: High Frequency [HF] (>0.15 Hz)
timeFrame: Day 1 (V1)
measure: High Frequency [HF] (>0.15 Hz)
timeFrame: Up to 40 days from V1 (V2)
measure: High Frequency [HF] (>0.15 Hz)
timeFrame: Up to 80 days from V1 (V3)
measure: High Frequency [HF] (>0.15 Hz)
timeFrame: Up to 180 days from V1 (V4)
measure: High Frequency [HF] (>0.15 Hz)
timeFrame: Up to 360 days from V1 (V5)
measure: Root Mean Square of Successive Differences [RMSSD]
timeFrame: Day 1 (V1)
measure: Root Mean Square of Successive Differences [RMSSD]
timeFrame: Up to 40 days from V1 (V2)
measure: Root Mean Square of Successive Differences [RMSSD]
timeFrame: Up to 80 days from V1 (V3)
measure: Root Mean Square of Successive Differences [RMSSD]
timeFrame: Up to 180 days from V1 (V4)
measure: Root Mean Square of Successive Differences [RMSSD]
timeFrame: Up to 360 days from V1 (V5)
measure: Skin conductance responses [SCR] frequency
timeFrame: Day 1 (V1)
measure: Skin conductance responses [SCR] frequency
timeFrame: Up to 40 days from V1 (V2)
measure: Skin conductance responses [SCR] frequency
timeFrame: Up to 80 days from V1 (V3)
measure: Skin conductance responses [SCR] frequency
timeFrame: Up to 180 days from V1 (V4)
measure: Skin conductance responses [SCR] frequency
timeFrame: Up to 360 days from V1 (V5)
measure: Skin conductance responses [SCR] amplitude
timeFrame: Day 1 (V1)
measure: Skin conductance responses [SCR] amplitude
timeFrame: Up to 40 days from V1 (V2)
measure: Skin conductance responses [SCR] amplitude
timeFrame: Up to 80 days from V1 (V3)
measure: Skin conductance responses [SCR] amplitude
timeFrame: Up to 180 days from V1 (V4)
measure: Skin conductance responses [SCR] amplitude
timeFrame: Up to 360 days from V1 (V5)
measure: Delta frequency (0-4Hz)
timeFrame: Day 1 (V1)
measure: Delta frequency (0-4Hz)
timeFrame: Up to 40 days from V1 (V2)
measure: Delta frequency (0-4Hz)
timeFrame: Up to 80 days from V1 (V3)
measure: Theta frequency (4-7Hz)
timeFrame: Day 1 (V1)
measure: Theta frequency (4-7Hz)
timeFrame: Up to 40 days from V1 (V2)
measure: Theta frequency (4-7Hz)
timeFrame: Up to 80 days from V1 (V3)
measure: Alpha frequency (8-12Hz)
timeFrame: Day 1 (V1)
measure: Alpha frequency (8-12Hz)
timeFrame: Up to 40 days from V1 (V2)
measure: Alpha frequency (8-12Hz)
timeFrame: Up to 80 days from V1 (V3)
measure: Beta frequency (13-30Hz)
timeFrame: Day 1 (V1)
measure: Beta frequency (13-30Hz)
timeFrame: Up to 40 days from V1 (V2)
measure: Beta frequency (13-30Hz)
timeFrame: Up to 80 days from V1 (V3)
measure: Gamma frequency (>30Hz)
timeFrame: Day 1 (V1)
measure: Gamma frequency (>30Hz)
timeFrame: Up to 40 days from V1 (V2)
measure: Gamma frequency (>30Hz)
timeFrame: Up to 80 days from V1 (V3)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Université de Montréal's affiliated Hospital Research Centre (CRCHUM)
state: Quebec
Study officials:
affiliation: Université de Montréal's affiliated hospital research centre
name: Dang Khoa Nguyen
role: PRINCIPAL_INVESTIGATOR
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