Heart Rate Variability Biofeedback for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Brigham Young University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Able to provide informed consent.

I am between 18 and 55 years old.

Fluent in English

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Exclusion Criteria

I have neurological issues like stroke or epilepsy.

You have been diagnosed with a learning disability.

You have a pacemaker implanted in your body.

See 3 more

Treatment Details

Interventions

OSC- (Behavioral Intervention)
OSC+ (Behavioral Intervention)

Trial OverviewThe 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.

Participant Groups

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).