Actively Recruiting
Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms
Led by Virginia Commonwealth University · Updated on 2025-09-17
148
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- History of military service
- Self-reported history of one or more mild traumatic brain injuries
- Most recent traumatic brain injury occurred more than one year ago
- Significant persistent post-concussion symptoms with Neurobehavioral Symptom Inventory (NSI) score of 20 or higher
- Current sleep difficulties
- Fluent in English
- Able to provide informed consent
You will not qualify if you...
- Any moderate or severe traumatic brain injury (loss of consciousness over 30 minutes, amnesia over 24 hours, or traumatic brain hemorrhage)
- Conditions or medications affecting heart rate variability measurement, including pacemaker or heart implants, recent heart surgery within the last year
- History of stroke
- Mental health conditions that may prevent study adherence, such as dementia, psychotic disorder, or panic disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
B
Brett Brooks
CONTACT
J
Jennifer Weggen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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