Heart Rate Variability Biofeedback Following Traumatic Brain Injury

Status unconfirmed · Early Phase 1 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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).

Key facts

Study ID

NCT05913505

Run by

Brigham Young University

People needed

50

Starts

2023-02-15

Expected to finish

2024-04-24

Last updated by the study team

2023-06-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Brigham Young University — Provo, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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