HRV Biofeedback for Functional Neurological Disorder

(HRV_BFB_FND Trial)

Overseen By Dang Khoa Nguyen, Pr

Age: 18+

Sex: Any

Trial Phase: Academic

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 This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

31 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 5 6 7 8}

How 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. ^{1 2 5 6 9}

Research Team

Dang Khoa Nguyen

Principal Investigator

Université de Montréal's affiliated hospital research centre

Eligibility 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

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.

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)

Treatment Details

Interventions

• HRV Biofeedback

Trial Overview 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).

Participant Groups

Group I: Experimental group (HRV-BFB training) Experimental Treatment 1 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 Group 1 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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Laboratoire de Psychologie et NeuroCognition

Collaborator

Trials

18

Recruited

1,300+

Findings from Research

In a study of 48 acute ischaemic stroke patients, HRV biofeedback significantly improved heart rate variability (HRV) and reduced autonomic symptoms after 3 months, indicating enhanced neurocardiac function.

The improvements in HRV were statistically significant, with measures like SDNN and RMSSD showing better results post-intervention compared to baseline, suggesting that HRV biofeedback may help modulate autonomic nervous system activity after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Sham-Controlled Pilot Study of Neurocardiac Function in Patients With Acute Ischaemic Stroke Undergoing Heart Rate Variability Biofeedback. Siepmann, T., Ohle, P., Sedghi, A., et al.[2021]

Individuals with severe brain injury can successfully modify their heart rate variability (HRV) through biofeedback, which is linked to improvements in emotional regulation and problem-solving abilities.

Increased HRV indices were associated with better attention scores and positive family ratings of emotional control, suggesting that HRV training may enhance cognitive functions in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart rate variability biofeedback, executive functioning and chronic brain injury. Kim, S., Zemon, V., Cavallo, MM., et al.[2014]

HRV biofeedback has been shown to produce immediate improvements in heart rate variability during practice, indicating its potential as a therapeutic tool for conditions associated with low HRV.

While there is strong evidence supporting the clinical efficacy of HRV biofeedback, the relationship between physiological improvements and clinical outcomes is not always consistent, suggesting that more research is needed to understand its mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback of heart rate variability and related physiology: a critical review. Wheat, AL., Larkin, KT.[2022]

A single session of heart rate variability biofeedback (HRV-BF) significantly improved heart rate variability (HRV) and reduced breathing rates in healthy college students compared to autogenic training (AT), indicating its efficacy in enhancing cardiac function.

Both HRV-BF and AT increased subjective relaxation scores, but HRV-BF showed a more pronounced effect on HRV indices, suggesting that integrating technology with psychological interventions can benefit various populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single Session of Heart Rate Variability Biofeedback Produced Greater Increases in Heart Rate Variability Than Autogenic Training. Lin, IM., Wang, SY., Fan, SY., et al.[2021]

Heart rate variability biofeedback (HRV-BF) significantly reduced hospital readmissions (12% vs. 25.42%) and emergency visits (13.33% vs. 35.59%) in patients with coronary artery disease over a 1-year period, indicating its effectiveness in improving cardiovascular prognosis.

The HRV-BF group showed long-term improvements in cardiac autonomic function and reductions in depression and hostility, suggesting that HRV-BF is a beneficial intervention for both psychological and physiological health in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Cardiovascular Prognosis of the Randomized, Controlled, Short-Term Heart Rate Variability Biofeedback Among Patients with Coronary Artery Disease. Yu, LC., Lin, IM., Fan, SY., et al.[2021]

The FitLab Game, a serious game designed to teach heart rate variability biofeedback (HRVB), showed significant improvements in heart rate variability (HRV) among participants who received training in breathing techniques, indicating its potential as an effective self-regulation tool.

Participants using the FitLab Game demonstrated enhanced performance and engagement, suggesting that the game's design effectively promotes attention and control, making it a promising intervention for managing arousal and improving self-control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Serious Game to Self-Regulate Heart Rate Variability as a Technique to Manage Arousal Level Through Cardiorespiratory Biofeedback: Development and Pilot Evaluation Study. Estrella, T., Alfonso, C., Ramos-Castro, J., et al.[2023]

Heart rate variability biofeedback (HRVB) is a safe and feasible non-drug treatment for chronic disease patients, showing no adverse effects across 29 studies.

HRVB demonstrated significant positive effects on various health issues, including hypertension, asthma, depression, and sleep disturbances, potentially improving patients' quality of life by enhancing heart rate variability and autonomic function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart rate variability biofeedback in chronic disease management: A systematic review. Fournié, C., Chouchou, F., Dalleau, G., et al.[2021]

Heart Rate Variability Biofeedback (HRVB) can improve cardiovascular health by utilizing different breathing protocols, with three main types identified: Optimal RF, Individual RF, and Preset-pace RF, based on 143 studies reviewed.

Many studies lack detailed reporting on HRVB protocols, making it difficult to replicate results; thus, the authors recommend methodological guidelines to improve the quality and transparency of future HRVB research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods for Heart Rate Variability Biofeedback (HRVB): A Systematic Review and Guidelines. Lalanza, JF., Lorente, S., Bullich, R., et al.[2023]

A three-week HRV biofeedback intervention with six 30-minute sessions significantly reduced depression and anxiety symptoms in older adults, with effect sizes indicating strong improvements (Cohen's d = 1.02 for depression and d = 0.82 for state anxiety).

Participants also showed enhanced attentional skills, as evidenced by improved performance on the Trail Making Test - Part A (Cohen's d = 1.00), suggesting that HRV biofeedback can be an effective treatment for cognitive and emotional issues in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart rate variability biofeedback: implications for cognitive and psychiatric effects in older adults. Jester, DJ., Rozek, EK., McKelley, RA.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Randomized Sham-Controlled Pilot Study of Neurocardiac Function in Patients With Acute Ischaemic Stroke Undergoing Heart Rate Variability Biofeedback. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Heart rate variability biofeedback, executive functioning and chronic brain injury. [2014]

3. Germany pubmed.ncbi.nlm.nih.gov

Biofeedback of heart rate variability and related physiology: a critical review. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

A Single Session of Heart Rate Variability Biofeedback Produced Greater Increases in Heart Rate Variability Than Autogenic Training. [2021]

5. England pubmed.ncbi.nlm.nih.gov

One-Year Cardiovascular Prognosis of the Randomized, Controlled, Short-Term Heart Rate Variability Biofeedback Among Patients with Coronary Artery Disease. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

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]

7. Scotland pubmed.ncbi.nlm.nih.gov

Heart rate variability biofeedback in chronic disease management: A systematic review. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Methods for Heart Rate Variability Biofeedback (HRVB): A Systematic Review and Guidelines. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Heart rate variability biofeedback: implications for cognitive and psychiatric effects in older adults. [2020]