Clinical Evaluation of HRV Biofeedback in Functional Neurological Disorders Compared to Placebo
- Conditions
- Functional Neurological Disorder
- Interventions
- Other: Pseudo HRV-BFBOther: Heart rate variability Biofeedback [HRV-BFB]
- Registration Number
- NCT06422819
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 31
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Control group (Pseudo HRV-BFB training) Pseudo HRV-BFB 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. Experimental group (HRV-BFB training) Heart rate variability Biofeedback [HRV-BFB] 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.
- Primary Outcome Measures
Name Time Method Patient Clinical Global Impression Score 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.
Clinician Clinical Global Impression Score 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.
Quality of life Score 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.
Self-perception of Occupation Score 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 Outcome Measures
Name Time Method Emotion Regulation Profile 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.
Trait anxiety score 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.
Depressive symptoms score 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.
Beta frequency (13-30Hz) 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.
Gamma frequency (>30Hz) 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.Other physical symptoms score 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.
Alexithymia score Day 1 (V1) Alexithymia score will be measured using the Toronto Alexithymia Scale (TAS-20; French version Loas, 1996). This scale includes 20 items.
Theta frequency (4-7Hz) 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.Quality of sleep measure 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.
Dissociative Experiences 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.
Childhood Trauma profile 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.
Root Mean Square of Successive Differences [RMSSD] 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 \[HRV\].
Brief Illness Perception score 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.
Skin conductance responses [SCR] frequency 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).
Skin conductance responses [SCR] amplitude 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).
Delta frequency (0-4Hz) 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.Positive Affect and Negative Affects 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.
High Frequency [HF] (>0.15 Hz) 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 \[HRV\].
Alpha frequency (8-12Hz) 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.
Trial Locations
- Locations (1)
Université de Montréal's affiliated Hospital Research Centre (CRCHUM)
🇨🇦Montréal, Quebec, Canada