Heart Rate Variability Biofeedback Following Traumatic Brain Injury

NCT05913505 | Unknown Early Phase 1

• 1 other identifier: TBI_HRVB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with mild traumatic brain injury will be randomly assigned to an active heart rate variability biofeedback condition and a sham condition. The investigators will use a randomized pre-post design that will consist of two data collection phases and a 5-week treatment condition. The heart rate variability biofeedback active condition is designed to increase heart rate oscillations (Osc+ condition) consistent with current best practices, while the sham control heart rate variability biofeedback condition is designed to decrease heart rate oscillations (Osc- condition).

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• Stress Recovery

  Test whether heart rate variability recovery following a stressor improves in individuals with mild traumatic brain injury following heart rate variability biofeedback

  Through study completion, an average of 7 weeks

• Resting HRV

  Examine whether heart rate variability increases at rest in individuals with mild traumatic brain injury from pre-treatment to post-treatment following heart rate variability biofeedback

  Through study completion, an average of 7 weeks

Secondary Outcomes (5)

• Physical Symptoms

  Through study completion, an average of 7 weeks

• Scale of Positive and Negative Experience

  Through study completion, an average of 7 weeks

• Depression Anxiety Stress Scales

  Through study completion, an average of 7 weeks

• Satisfaction with Life Scale

  Through study completion, an average of 7 weeks

• Cognitive Functioning

  Through study completion, an average of 7 weeks

Study Arms (2)

OSC+

EXPERIMENTAL

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.

Behavioral: OSC+

OSC-

SHAM COMPARATOR

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).

Behavioral: OSC-

Interventions

OSC- BEHAVIORAL

During the first week, the baseline will be assessed and resonance frequency. Specifically, during their first intervention session the participants will be told that the goal of the sessions includes decreasing heart rate variability and avoiding slow and steady breathing. The participants will then be asked to choose five strategies to lower their heart rate oscillations. Participants will be told to avoid slow breathing as it causes large heart rate oscillations. For the second session, the therapist will check in with the participant and discuss how the practice went. Participants will then select three strategies that they will practice for three five-minute conditions following a five-minute baseline. Sessions three, four, and five will include three conditions: a five-minute baseline and two strategies of their choice. For each session, the best strategy will be calculated and written on the assignment sheets to be used during the week for their four homework sessions.

OSC-

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At least six months post-injury to account for spontaneous recovery
• Aged 18-55 years
• Fluent in English
• Able to provide informed consent.

You may not qualify if:

• Presence of a pacemaker
• Previous self-reported heart attack with hospitalization
• Diagnosed learning disability
• Other neurological difficulties or diagnoses (i.e., stroke, epilepsy)
• Participation in current litigation
• Uncorrected visual impairment.

Sponsors & Collaborators

• Brigham Young University: lead

Study Sites (1)

Brigham Young University

Provo, Utah, 84606, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Michael J Larson, PhD

  Brigham Young University

  STUDY CHAIR

Central Study Contacts

Leah D Talbert, MS

CONTACT

3343141078; [email protected]

Michael J Larson, PhD

CONTACT

8014226125; [email protected]

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Baseline measurements will be collected by undergraduate research assistants blinded to group conditions to reduce possible experimenter bias effects. Additionally, research assistants will be blinded to conditions for all testing sessions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Twenty-five participants will complete the treatment condition in a pseudo-randomized order (determined by random number generator with constraints) such that half of the participants will be given the heart rate variability biofeedback active condition and half will be given the sham control condition. However, the participants in the sham control condition will be offered treatment with heart rate variability biofeedback after study completion. The heart rate variability biofeedback active condition is designed to increase heart rate oscillations (Osc+ condition) consistent with current best practices, while the sham control heart rate variability biofeedback condition is designed to decrease heart rate oscillations (Osc- condition).

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: June 22, 2023
• Study Start: February 15, 2023
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Once data collection and data analysis has been completed and published in a scientific journal, the study data (de-identified) will either be posted on an open science website, such as the Open Science Framework, or will be given to other researchers upon request.

Locations

US (1)