Heart rate variability biofeedback for recovery after brain injury
A Randomized Controlled Trial of Heart Rate Variability Biofeedback Following Traumatic Brain Injury
This study is testing if a heart rate biofeedback program can help people with mild brain injuries feel better and recover faster after stress.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Brigham Young University Academic / other |
| Locations | 1 site (Provo, Utah) |
| Trial ID | NCT05913505 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of heart rate variability biofeedback on individuals with mild traumatic brain injury. Participants will be randomly assigned to either an active biofeedback condition aimed at increasing heart rate oscillations or a sham condition designed to decrease them. The study will measure changes in heart rate variability before and after a 5-week treatment period, as well as recovery following stressors. The goal is to determine if biofeedback can improve heart rate variability and associated physical symptoms in this population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-55 who are at least six months post-injury and fluent in English.
Not a fit: Patients with a pacemaker, previous heart attacks, or other significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and reduce symptoms in patients with mild traumatic brain injury.
How similar studies have performed: While the specific approach of heart rate variability biofeedback in this context is novel, similar interventions have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Provo, Utah
- Brigham Young University — Provo, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Leah D Talbert, MS
- Email: leah.d.whitlow@gmail.com
- Phone: 3343141078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.