Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms (NCT07071350)
🩺 Plain-English Summary (8th-Grade Level)
Many combat veterans (c-Vs), service members (SMs) and civilians with mild traumatic brain injury (mTBI, also termed concussion) suffer from persistent post-concussion symptoms (PPCS) that degrade physical and cognitive well-being and have been linked with early neurodegeneration. PPCS include somatosensory (e.g., headache, disturbed vision), vestibular (e.g., dizzy, clumsy), cognitive (e.g., executive function, memory) and affective symptoms (e.g., sleep disturbance, irritability, depression). A key pathological process that provokes and perpetuates PPCS is autonomic nervous system (ANS) dysfunction such as unremitting sympathetic nervous system activation that also exacerbates other pathology such as inflammation. ANS activity can be readily quantified by measuring heart rate variability (HRV), or the variation in heart rate over time, which serves as a valid index of both physiological and psychological health
Who can join: Review the eligibility criteria below.
Location: Virginia Commonwealth University — Richmond, Virginia
Age range: 18 Years
🧪 Interventions in This Study
- HRV Coherence Ratio (OTHER)
- NSI (BEHAVIORAL)
- Pittsburgh Sleep Quality Index (PSQI) (BEHAVIORAL)
- Quantitative Sleep Measures (BEHAVIORAL)
- Patient Global Impression of Change (PGIC) (BEHAVIORAL)
- Cognitive Performance/NIH Toolbox Cognitive Battery (BEHAVIORAL)
- Pain Interference/TBI-QoL Pain Interference Short-Form (OTHER)
- Patient Health Questionnaire-9 (PHQ-9) (BEHAVIORAL)
- PTSD Checklist for DSM-5 (PCL-5) (BEHAVIORAL)
- HRV Biofeedback (HRV-B) (OTHER)
- Psychoeducational (Edu) Comparator Intervention (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Virginia Commonwealth University — Richmond, Virginia
📞 Contact the Study Coordinator
Phone: (804) 827-9692
Email: bret.brooks@vcuhealth.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Autonomic Nervous System Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.