Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms
Start Date
9/2/2025
Completion Date
9/1/2028
Summary
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
Detailed Description
This study, a randomized, controlled trial (RCT) of an easily implemented, mechanism-driven, behavioral intervention using HRV biofeedback (HRV-B) to treat PPCS among adults, including c-Vs and SMs, with history of single or repeated mTBI from blast-related or other mechanism. Specifically, we study an intervention for persons with PPCS that promotes sustained functional recovery during the chronic phase of injury, which addresses psychological health and cognitive functioning, and has the potential to address neurodegenerative processes associated with TBI and treat co-occurring TBI and psychological health conditions. Importantly, the intervention is non-invasive, rapidly deployable, and is based on the pathophysiology and a theoretical mechanism of PPCS. Secondarily, this project also has the potential as a more generalized solution to increase readiness and psychological resilience in individuals, small teams, families, and communities to ameliorate the potential negative impacts of specific military and life stressors.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
HRV Coherence Ratio
NSI
Pittsburgh Sleep Quality Index (PSQI)
Quantitative Sleep Measures
Patient Global Impression of Change (PGIC)
Cognitive Performance/NIH Toolbox Cognitive Battery
Pain Interference/TBI-QoL Pain Interference Short-Form
Patient Health Questionnaire-9 (PHQ-9)
PTSD Checklist for DSM-5 (PCL-5)
HRV Biofeedback (HRV-B)
Psychoeducational (Edu) Comparator Intervention
Conditions
Locations
Virginia Commonwealth University
Richmond, Virginia 23298
United States