What is the mechanism of action of this treatment?

Heart Rate Variability (HRV) Biofeedback is a treatment that aims to improve autonomic nervous system function by training patients to control their heart rate oscillations. This is achieved through real-time feedback that helps patients learn to regulate their breathing and heart rate, promoting a state of physiological coherence. For Traumatic Brain Injury (TBI) patients, this is particularly important as it can help mitigate symptoms such as anxiety, stress, and impaired autonomic function, which are common after TBI. By enhancing autonomic regulation, HRV Biofeedback can contribute to better overall recovery and improved quality of life for TBI patients.

What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) include medications, rehabilitation therapies, and biofeedback techniques such as Heart Rate Variability (HRV) Biofeedback. Medications can have side effects like dizziness, nausea, and fatigue. Rehabilitation therapies, including physical, occupational, and speech therapy, may lead to temporary discomfort or fatigue. HRV Biofeedback, which aims to modulate heart rate oscillations, is generally considered safe but may cause mild side effects such as lightheadedness or temporary changes in heart rate. Overall, these treatments are aimed at improving neurological function and quality of life in TBI patients.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Traumatic Brain Injury (TBI) that focus on Heart Rate Variability (HRV) Biofeedback or modulation of heart rate oscillations. Current FDA-approved treatments for TBI primarily involve medications to manage symptoms such as pain, seizures, and spasticity, as well as rehabilitation therapies. HRV biofeedback is an emerging area of interest in TBI rehabilitation, but it is still under investigation and not yet approved by the FDA for this specific use.

What other types of research exist?

Promising novel alternatives to Heart Rate Variability Biofeedback for TBI patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving cognitive function and reducing symptoms of inattention. 2) Neurofeedback, which involves training patients to regulate brain activity and has demonstrated improvements in neurocognitive functioning. 3) Vagus Nerve Stimulation (VNS), which has been explored for its potential benefits in neurorehabilitation and mood regulation. These therapies are supported by recent clinical trials and systematic reviews indicating their efficacy and safety.

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Behavioral Intervention

Heart Rate Variability Biofeedback for Traumatic Brain Injury

Phase < 1

Recruiting

Research Sponsored by Brigham Young University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18-55 years

Be between 18 and 65 years old

Must not have

Other neurological difficulties or diagnoses (i.e., stroke, epilepsy)

Uncorrected visual impairment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 7 weeks

Summary

This trial tests if heart rate variability biofeedback can help people with mild traumatic brain injury improve their heart rate patterns and recover better from stress. The study will compare those who receive the biofeedback training to those who do not, to see if the training leads to better physical, emotional, and cognitive health. Heart rate variability (HRV) biofeedback has been explored as a method to improve emotion regulation and social functioning in individuals with severe traumatic brain injury.

Who is the study for?

This trial is for individuals aged 18-55 who have had a mild traumatic brain injury at least six months ago, speak English fluently, and can consent to participate. It's not for those with pacemakers, past severe heart attacks, learning disabilities, other neurological issues like stroke or epilepsy, involvement in litigation related to their injury, or uncorrected vision problems.

What is being tested?

The study compares two types of heart rate variability biofeedback treatments for people with traumatic brain injury: one that aims to increase heart rate oscillations (OSC+) and another that decreases them (OSC-). Participants will be randomly placed into either the active treatment or sham condition over five weeks.

What are the potential side effects?

Since this trial involves non-invasive biofeedback therapy rather than medication or surgery, side effects are minimal but may include discomfort from wearing the device used to monitor heart rate variability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have neurological issues like stroke or epilepsy.

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I have vision problems that glasses or contacts can't fix.

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I have been hospitalized for a heart attack before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 7 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Resting HRV

Stress Recovery

Secondary study objectives

Cognitive Functioning

Depression Anxiety Stress Scales

Physical Symptoms

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OSC+Experimental Treatment1 Intervention

Twenty-five participants will complete five weeks of heart rate variability biofeedback using emWave software (HeartMath®Institute, 2020). Participants will receive a weekly 30-minute heart rate variability biofeedback session for five weeks at the University Parkway Center, Brigham Young University. The heart rate variability biofeedback protocol will be based on Lehrer et al., 2013 and Yoo et al., 2022. This format will aid participants in implementing and learning breathing and heart rate variability biofeedback skills (Lehrer et al., 2020). All participants will wear an ear sensor to measure their pulse. The heart rate variability biofeedback will focus on autonomic balance through slow breathing at a resonance frequency of approximately 6 breathes per minute. The best approximate breathing pace for resonance frequency will be estimated and participant's resonance frequency will be provided and used for their homework and subsequent training sessions.

Group II: OSC-Placebo Group1 Intervention

Twenty-five participants will complete five weeks of Osc-. Similarly, for the Osc- procedures, the client will be required to complete a five-week intervention. During the weekly session, participants will also be wearing an earlobe monitor with HeartMath. Participants will be administered the Scale of Positive and Negative Experience at the beginning of each session to assess for mood. Participants will also be administered the 3-item Rivermead Post Concussion Symptoms Questionnaire at the beginning of each session. Participants will be instructed that the purpose of this portion of the study is to decrease their breathing oscillations. A program was designed by Yoo and colleagues (2022) that gives feedback regarding a "calmness" score which reflects a better score (i.e., higher) when participants breath in a pattern that elicits less variability (i.e., less oscillations).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OSC+

2023

Completed Early Phase 1

~60

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Heart Rate Variability (HRV) Biofeedback is a treatment that aims to improve autonomic nervous system function by training patients to control their heart rate oscillations. This is achieved through real-time feedback that helps patients learn to regulate their breathing and heart rate, promoting a state of physiological coherence. For Traumatic Brain Injury (TBI) patients, this is particularly important as it can help mitigate symptoms such as anxiety, stress, and impaired autonomic function, which are common after TBI. By enhancing autonomic regulation, HRV Biofeedback can contribute to better overall recovery and improved quality of life for TBI patients.

In search of evidence-based treatment for concussion: characteristics of current clinical trials.