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NCT07071350 · ClinicalTrials.gov registry record · Phase 2
Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms
A Phase 2 study of Post Traumatic Stress Disorder and Mild Traumatic Brain Injury, sponsored by Virginia Commonwealth University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 148
- Enrollment target
- 1
- Study location
NCT07071350: Recruiting Phase 2 study of Post Traumatic Stress Disorder and Mild Traumatic Brain Injury, sponsored by Virginia Commonwealth University.
NCT07071350 is a Phase 2 study of Post Traumatic Stress Disorder and Mild Traumatic Brain Injury that is actively recruiting participants, run by Virginia Commonwealth University. The registered enrollment target is 148 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07071350, a Phase 2 study of Post Traumatic Stress Disorder and Mild Traumatic Brain Injury, is actively recruiting participants, sponsored by Virginia Commonwealth University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 148 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
The Neurobehavioral Symptom Inventory (NSI) is a 22-item self-report questionnaire used to assess the severity of neurobehavioral symptoms following traumatic brain injury (TBI), particularly postconcussion symptoms. It's a widely used tool in TBI research and clinical evaluation by the Department of Defense and Department of Veterans Affairs. The total score ranges from 0 to 88, with higher scores indicating more severe post-concussive symptoms
Conditions Studied
Interventions
- OTHER HRV Coherence Ratio
- BEHAVIORAL NSI
- BEHAVIORAL Pittsburgh Sleep Quality Index (PSQI)
- BEHAVIORAL Quantitative Sleep Measures
- BEHAVIORAL Patient Global Impression of Change (PGIC)
Study Locations (1)
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2025-09-02 |
| Est. Completion | 2028-09 |
| Phase | Phase 2 |
What NCT07071350 shows while recruiting
NCT07071350 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (78% lower).
The record links to 5 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 5 interventions - of which HRV Coherence Ratio is the first listed.
NCT07071350 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT07071350 about?
NCT07071350 is a clinical study titled "Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms". 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 somat...
What is the current status of trial NCT07071350?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2025-09-02. Estimated completion is 2028-09.
What conditions does trial NCT07071350 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Mild Traumatic Brain Injury, Autonomic Nervous System Disease, Persistent Post Concussion Syndrome, Concussive Injury.
What interventions are being tested in trial NCT07071350?
The interventions under investigation include: HRV Coherence Ratio (OTHER), NSI (BEHAVIORAL), Pittsburgh Sleep Quality Index (PSQI) (BEHAVIORAL), Quantitative Sleep Measures (BEHAVIORAL), Patient Global Impression of Change (PGIC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT07071350?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07071350 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07071350's enrollment target sits among peer trials
148 80th of 262 higher than 182 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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