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

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Interventions: Cognitive Performance/NIH Toolbox Cognitive Battery (Behavioral), HRV Biofeedback (HRV-B) (Other), HRV Coherence Ratio (Other), NSI… to Cognitive Performance/NIH Toolbox Cognitive Battery (Behavioral), HRV Biofeedback (HRV-B) (Other), HRV Coherence Ratio (Other), NSI…
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 4 of 5 entries
  2. Start date changed from estimate of Aug 2025 to Sep 2, 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07071350
Lead Sponsor Virginia Commonwealth University
Collaborators: United States Department of Defense
Conditions
(from sponsor)		 Autonomic Nervous System Disease, Concussive Injury, Mild Traumatic Brain Injury, Post Traumatic Stress Disorder, Persistent Post Concussion Syndrome
Related terms Brain Concussion, Stress Disorders, Post-Traumatic
Enrollment 148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov