About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- 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
Treatment groups
Sponsors and collaborators
Virginia Commonwealth University
Lead sponsor
United States Department of Defense
Collaborator