Treatment to improve heart rate variability for long-term concussion symptoms
Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms
This trial tests whether a non-invasive heart rate variability biofeedback program can reduce long-term post-concussion symptoms in adults with a history of mild TBI, including veterans and service members.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT07071350 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled trial uses a mechanism-driven behavioral intervention—heart rate variability biofeedback (HRV-B)—to target autonomic nervous system dysfunction that may perpetuate persistent post-concussion symptoms (PPCS). Adults with prior mild TBI and significant PPCS (including military veterans and service members) are randomized to receive HRV-B versus control and followed using symptom inventories, sleep measures, HRV metrics, and global impression scales. The intervention is non-invasive, rapidly deployable, and designed to improve autonomic balance, sleep, cognitive function, and psychological health. Secondary aims include exploring effects on readiness and resilience and potential implications for longer-term neurodegenerative risk after TBI.
Who should consider this trial
Good fit: Adults aged 18 or older with a history of military service, one or more prior mild TBIs, persistent post-concussion symptoms (NSI score ≥20), current sleep difficulties, most recent TBI more than one year ago, and ability to consent in English.
Not a fit: Patients with moderate or severe TBI, recent (<1 year) TBI, implanted cardiac devices or other conditions/medications that interfere with HRV measurement, or other exclusionary medical issues are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, the intervention could reduce PPCS severity, improve sleep and cognitive/affective symptoms, and restore healthier autonomic (HRV) patterns using a non-invasive behavioral approach.
How similar studies have performed: HRV biofeedback has shown promising results in small studies for PTSD, anxiety, and symptom reduction after TBI, but large definitive randomized trials in PPCS are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18 or older * History of military service * Self-Reported hx of 1 or more mild TBI * Most recent TBI more than 1 year ago * Significant Persistent Post-Concussion Symptom burden (Neurobehavioral Symptom Inventory \[NSI\] total score greater than or equal to 20). * Current Sleep Difficulties * Fluent English * Able to provide Informed Consent Exclusion Criteria: * Any TBI with severity greater than mild (i.e., Moderate or Severe TBI defined as initial injury loss of consciousness (LOC) duration \>30 minutes, posttraumatic amnesia (PTA) duration \>24 hours, or traumatic hemorrhage on head computerized tomography (CT) and determined by the study investigator based on information gathered during administration of the study's validated TBI structured interview instrument. * Conditions or medications that can affect HRV measurement (pacemaker or an implant that stimulates your heart (e.g., cardioverter-defibrillator or ICD); heart transplant or heart surgery within the last year, including bypass or other surgery, but not including a stent) * Hx of stroke * Mental conditions that may impede adherence (e.g., dementia, psychotic disorder, panic disorder)
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: James Burch — Virginia Commonwealth University
- Study coordinator: Brett Brooks
- Email: bret.brooks@vcuhealth.org
- Phone: (804) 827-9692
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.