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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Virginia Commonwealth University
Richmond, Virginia, United States
Start Date
September 2, 2025
Primary Completion Date
September 1, 2028
Completion Date
September 1, 2028
Last Updated
September 17, 2025
148
ESTIMATED participants
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
Lead Sponsor
Virginia Commonwealth University
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07202494