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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 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 1,116-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07071350
The ClinicalTrials.gov registry entry for NCT07071350 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,116-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (87% lower). The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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