Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

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

148 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Virginia Commonwealth University

Lead sponsor

United States Department of Defense

Collaborator