HRV Biofeedback for Functional Neurological Disorder
(HRV_BFB_FND Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Must not be taking: Anticholinergics, Beta-blockers, Tricyclics, others
Disqualifiers: Severe psychiatric, Alcohol dependence, Autonomic dysfunctions, others
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo.
Will I have to stop taking my current medications?
If you are taking medications that affect the autonomic nervous system, like certain heart or depression medications, you may need to stop them to join this trial.
What data supports the effectiveness of the treatment HRV Biofeedback for Functional Neurological Disorder?
Research shows that HRV biofeedback can improve heart rate variability and reduce symptoms related to the autonomic nervous system (which controls involuntary actions like heartbeat) in stroke patients. It has also been shown to enhance emotional regulation and problem-solving in people with brain injuries, suggesting it may help with similar issues in Functional Neurological Disorder.
12345Is HRV Biofeedback safe for humans?
HRV Biofeedback has been used safely in various studies for conditions like stroke and coronary artery disease, with no significant safety concerns reported.
15678How is HRV Biofeedback treatment different from other treatments for Functional Neurological Disorder?
HRV Biofeedback is unique because it helps patients learn to control their heart rate variability through real-time feedback, which can improve autonomic nervous system function and emotional regulation. Unlike other treatments, it focuses on self-regulation and enhancing parasympathetic activity, which may not be addressed by standard therapies.
12569Eligibility Criteria
This trial is for individuals with Functional Neurological Disorders, which can include symptoms like uncontrolled movements or blackouts without a clear physical cause. Participants should be diagnosed with conditions such as Conversion Disorder or similar nervous system disorders.Inclusion Criteria
I am legally considered an adult in my country.
Participants must have a smartphone (android or iPhone)
Participants must have signed an informed consent
+4 more
Exclusion Criteria
Participants under judicial or administrative supervision
Participants suffering from a severe psychiatric disease needing specialized attention
I have a history of serious brain or nerve surgery problems.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Comprehensive clinical evaluation including symptoms, functional capacity, quality of life, and assessment of physical and psychological comorbidities
1-2 weeks
1 visit (in-person)
Treatment
Participants undergo HRV Biofeedback training or placebo training using Inner Balance Coherence Plus® software for 30 days
4 weeks
2 visits (in-person)
Crossover Treatment
Participants switch to the alternate intervention (HRV-BFB or placebo) for another 30 days
4 weeks
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including repeated measures of symptoms, functional capacity, and quality of life
Up to 360 days
Multiple visits (in-person and virtual)
Participant Groups
The study is testing the effectiveness of Heart Rate Variability Biofeedback (HRV-BFB), a technique that may help patients control their body's responses to stress, compared to a placebo version of the same procedure (Pseudo HRV-BFB).
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental group (HRV-BFB training)Experimental Treatment1 Intervention
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.
Group II: Placebo Control group (Pseudo HRV-BFB training)Placebo Group1 Intervention
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.
HRV Biofeedback is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as HRV Biofeedback for:
- Anxiety disorders
- Depression
- Hypertension
- Temporomandibular joint (TMJ) syndrome
- Urinary incontinence
- Fecal incontinence
- Irritable bowel syndrome
- Migraine and tension headaches
🇪🇺 Approved in European Union as HRV Biofeedback for:
- Anxiety disorders
- Depression
- Hypertension
- Temporomandibular joint (TMJ) syndrome
- Urinary incontinence
- Fecal incontinence
- Irritable bowel syndrome
- Migraine and tension headaches
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Université de Montréal's affiliated Hospital Research Centre (CRCHUM)Montréal, Canada
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
Laboratoire de Psychologie et NeuroCognitionCollaborator
References
Randomized Sham-Controlled Pilot Study of Neurocardiac Function in Patients With Acute Ischaemic Stroke Undergoing Heart Rate Variability Biofeedback. [2021]Background: Neurocardiac dysfunction worsens clinical outcome and increases mortality in stroke survivors. We hypothesized that heart rate variability (HRV) biofeedback improves neurocardiac function by modulating autonomic nervous system activity after acute ischaemic stroke (AIS). Methods: We randomly allocated (1:1) 48 acute ischaemic stroke patients to receive nine sessions of HRV- or sham biofeedback over 3 days in addition to comprehensive stroke unit care. Before and after the intervention patients were evaluated for HRV via standard deviation of normal-to-normal intervals (SDNN, primary outcome), root mean square of successive differences between normal heartbeats (RMSSD), a predominantly parasympathetic measure, and for sympathetic vasomotor and sudomotor function. Severity of autonomic symptoms was assessed via survey of autonomic symptom scale total impact score (TIS) at baseline and after 3 months. Results: We included 48 patients with acute ischaemic stroke [19 females, ages 65 (4.4), median (interquartile range)]. Treatment with HRV biofeedback increased HRV post intervention [SDNN: 43.5 (79.0) ms vs. 34.1 (45.0) ms baseline, p = 0.015; RMSSD: 46.0 (140.6) ms vs. 29.1 (52.2) ms baseline, p = 0.015] and alleviated autonomic symptoms after 3 months [TIS 3.5 (8.0) vs. 7.5 (7.0) baseline, p = 0.029], which was not seen after sham biofeedback (SDNN: p = 0.63, RMSSD: p = 0.65, TIS: 0.06). There were no changes in sympathetic vasomotor and sudomotor function (p = ns). Conclusions: Adding HRV biofeedback to standard stroke unit care led to improved neurocardiac function and sustained alleviation of autonomic symptoms after acute ischaemic stroke, which was likely mediated by a predominantly parasympathetic mechanism. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03865225.
Heart rate variability biofeedback, executive functioning and chronic brain injury. [2014]To determine if individuals with brain injury can modify heart rate variability (HRV) through biofeedback and, if so, enhance its pattern to improve emotional regulation and problem-solving ability.
Biofeedback of heart rate variability and related physiology: a critical review. [2022]Low heart rate variability (HRV) characterizes several medical and psychological diseases. HRV biofeedback is a newly developed approach that may have some use for treating the array of disorders in which HRV is relatively low. This review critically appraises evidence for the effectiveness of HRV and related biofeedback across 14 studies in improving (1) HRV and baroreflex outcomes and (2) clinical outcomes. Results revealed that HRV biofeedback consistently effectuates acute improvements during biofeedback practice, whereas the presence of short-term and long-term carry-over effects is less clear. Some evidence suggests HRV biofeedback may result in long-term carry-over effects on baroreflex gain, which is an area most promising for future investigations. On the other hand, concerning clinical outcomes, there is ample evidence attesting to efficacy of HRV biofeedback. However, because clinical and physiological outcomes do not improve concurrently in all cases, the mechanism by which HRV biofeedback results in salutary effects in unclear. Considerations for the field in addressing shortcomings of the reviewed studies and advancing understanding of the way in which HRV biofeedback may improve physiological and clinical outcomes are offered in light of the reviewed evidence.
A Single Session of Heart Rate Variability Biofeedback Produced Greater Increases in Heart Rate Variability Than Autogenic Training. [2021]Heart rate variability biofeedback (HRV-BF) has been confirmed to increase heart rate variability (HRV) and cardiac outflows by baroreflex in healthy populations and clinical patients. Autogenic training (AT) is common used in the psychological intervention. This study integrates a single-session of HRV-BF and AT into a high-technology mobile application (app), and examines the effects on HRV indices, breathing rates, and subjective relaxation scores. Healthy college students were recruited and assigned to the single-session HRV-BF group or AT group. Participants in the HRV-BF group received HRV-BF combined with paced breathing training, which gradually stepped down their breathing rates from 12, to 8, to 6 breaths/per min; and received feedback of HRV indices from the app. Participants in the AT group received autogenic training and feedback of heart rate from the app. A chest belt Zephyr BioHarness was connected through Bluetooth to a Zenfone5 mobile phone, it collected the signals of interbeat intervals and breathing rates at pre-training, mid-training, and post-training stages. The Kubios HRV software was used to analyze HRV indices. The results reveal higher HRV indices and lower breathing rates during mid-training and post-training in the HRV-BF group compared to the AT group. There were higher high-frequency of HRV at post-training than pre-training in the AT group. Participants of both groups increased their subjective relaxation scores after training. The HRV-BF protocol increased cardiac outflows by baroreflex and decreased breathing rates, and the AT protocol increased high-frequency of HRV. These high-technology wearable devices combined with psychological interventions will apply to various populations in the future.
One-Year Cardiovascular Prognosis of the Randomized, Controlled, Short-Term Heart Rate Variability Biofeedback Among Patients with Coronary Artery Disease. [2021]Heart rate variability biofeedback (HRV-BF) is an effective psychophysiological intervention, with short-term effects of increased autonomic nervous system homeostasis, strengthened baroreflex sensitivity, and decreased hostility in patients with coronary artery disease (CAD). The study examined the 1-year HRV-BF effect on cardiovascular prognosis of these patients.
A Serious Game to Self-Regulate Heart Rate Variability as a Technique to Manage Arousal Level Through Cardiorespiratory Biofeedback: Development and Pilot Evaluation Study. [2023]Heart rate variability biofeedback (HRVB) is an established intervention for increasing heart rate variability (HRV) in the clinical context. Using this technique, participants become aware of their HRV through real-time feedback and can self-regulate it.
Heart rate variability biofeedback in chronic disease management: A systematic review. [2021]Heart rate variability biofeedback (HRVB) is a non-pharmacological intervention used in the management of chronic diseases.
Methods for Heart Rate Variability Biofeedback (HRVB): A Systematic Review and Guidelines. [2023]Heart Rate Variability Biofeedback (HRVB) has been widely used to improve cardiovascular health and well-being. HRVB is based on breathing at an individual's resonance frequency, which stimulates respiratory sinus arrhythmia (RSA) and the baroreflex. There is, however, no methodological consensus on how to apply HRVB, while details about the protocol used are often not well reported. Thus, the objectives of this systematic review are to describe the different HRVB protocols and detect methodological concerns. PsycINFO, CINALH, Medline and Web of Science were searched between 2000 and April 2021. Data extraction and quality assessment were based on PRISMA guidelines. A total of 143 studies were finally included from any scientific field and any type of sample. Three protocols for HRVB were found: (i) "Optimal RF" (n = 37), each participant breathes at their previously detected RF; (ii) "Individual RF" (n = 48), each participant follows a biofeedback device that shows the optimal breathing rate based on cardiovascular data in real time, and (iii) "Preset-pace RF" (n = 51), all participants breathe at the same rate rate, usually 6 breaths/minute. In addition, we found several methodological differences for applying HRVB in terms of number of weeks, duration of breathing or combination of laboratory and home sessions. Remarkably, almost 2/3 of the studies did not report enough information to replicate the HRVB protocol in terms of breathing duration, inhalation/exhalation ratio, breathing control or body position. Methodological guidelines and a checklist are proposed to enhance the methodological quality of future HRVB studies and increase the information reported.
Heart rate variability biofeedback: implications for cognitive and psychiatric effects in older adults. [2020]Two decades of heart rate variability (HRV) biofeedback research have focused on adolescent and adult populations with a variety of symptoms and conditions at the exclusion of older adults. This study explores HRV biofeedback as a novel treatment to decrease psychiatric symptoms and improve cognitive functioning in older adults.