Heart Rate Variability Biofeedback Following Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

A Randomized Controlled Trial of Heart Rate Variability Biofeedback Following Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913505
• Other study ID #: TBI_HRVB
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 15, 2023
• Est. completion date: April 24, 2024

Study information

• Verified date: June 2023
• Source: Brigham Young University
• Contact: Leah D Talbert, MS
• Phone: 3343141078
• Email: leah.d.whitlow[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

There are two primary aims of the study: (1) 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; (2) to test whether heart rate variability recovery following a stressor improves in individuals with mild traumatic brain injury following heart rate variability biofeedback. Regarding the first primary aim, the investigators hypothesize that heart rate variability will be higher in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to those in the control/sham condition where the investigators do not expect such improvement pre- to post-testing. For the second aim, consistent with previous work, the investigators hypothesize that heart rate variability recovery following a stressor will be faster in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to a sham control condition. There are three secondary aims for this study: (1) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in physical symptoms common after head injury (i.e., headaches, dizziness, sleep disturbance); (2) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in emotional functioning (i.e., life satisfaction, anxiety symptoms, depression symptoms); and (3) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in cognitive functioning (i.e., attention, inhibitory control).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 24, 2024
• Est. primary completion date: April 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• At least six months post-injury to account for spontaneous recovery

• Aged 18-55 years

• Fluent in English

• Able to provide informed consent.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• OSC+
The first session of the HRVB intervention will focus on introducing the client to HRVB and calculating the participant's resonance frequency which typically range from 4.5-7 breaths per minute. Participants will first complete a five-minute baseline breathing condition. Following the breathing condition, the participants will complete five conditions for five minutes each. Specifically, each condition will have the person breath at 6, 6.5, 5.5, 5, and 4.5 breaths per minute with a minute break between. Session two will focus on practicing resonance frequency breathing and solidifying the correct resonance frequency for the participant. Additionally, this session will introduce the technique of breathing through pursed lips and abdominal breathing. For sessions three through five, participants will practice resonance frequency breathing and review previous strategies.
• OSC-
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.

Locations

Country	Name	City	State
United States	Brigham Young University	Provo	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Brigham Young University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Physical Symptoms	The Rivermead Post Concussion Symptoms Questionnaire is a 16-item self-report measure of the severity of post-concussive symptoms following traumatic brain injury. The scale includes three categories of behavioral, physical, and cognitive symptoms, where participants are asked to rate the degree to which they experience 16 concussive symptoms in comparison to pre-injury symptoms within the past 24 hours. The items are rated on a 5-point scale from 0 (not experienced at all) to 4 (a severe problem). The RPQ-13 and RPQ-3 have good internal consistency and good test-retest reliability (0.89 and 0.72, respectively).	Through study completion, an average of 7 weeks
Secondary	Scale of Positive and Negative Experience	The Scale of Positive and Negative Experience is a 12-item scale that assesses participant experiences in various states (e.g., sad, happy, afraid) on a 5-point scale from 1 (never) to 5 (always).	Through study completion, an average of 7 weeks
Secondary	Depression Anxiety Stress Scales	The Depression Anxiety Stress Scales is a three-part self-report measure consisting of 42 items related to negative emotional states of tension/stress, anxiety, and depression. Each scale contains subscales of 2-4 items totaling 14 items. Each scale contains a four-point scale of severity and frequency to be rated on experiences over the past week.	Through study completion, an average of 7 weeks
Secondary	Satisfaction with Life Scale	The Satisfaction with Life Scale assesses judgments of one's life satisfaction using a 5-item scale. Scores are reported on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). While the scale does not assess life satisfaction across multiple domains, it quantifies a global measure of subjective well-being. Total scores range from 7 to 35, with higher scores indicating higher satisfaction.	Through study completion, an average of 7 weeks
Secondary	Cognitive Functioning	The NIH Toolbox for the Assessment of Neurological Behavior and Function Cognition Battery is approximately 30 minutes and consists of seven measures, including Picture Vocabulary, Oral Reading Recognition, Picture Sequence Memory, Dimensional Change Card Sort Test, List Sorting Working Memory, Flanker Inhibitory Control and Attention Test, and Pattern Comparison Processing Speed. The NIHTB-CB consists of two composite scores: a Crystallized Cognition Composite Score, providing a pre-injury estimate of overall cognitive ability, which is a combined score of Picture Vocabulary and Oral Reading Recognition; and a Fluid Cognition Composite Score, which is a combined score of Picture Sequence Memory, Dimensional Change Card Sort Test, List Sorting Working Memory, Flanker Inhibitory Control and Attention Test, and Pattern Comparison Processing Speed. The age-adjusted scaled score has a mean of 100 and a standard deviation of 15.	Through study completion, an average of 7 weeks