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

> **NCT07071350** · PHASE2,PHASE3 · RECRUITING · sponsor: **Virginia Commonwealth University** · enrollment: 148 (estimated)

## Conditions studied

- Autonomic Nervous System Disease
- Concussive Injury
- Mild Traumatic Brain Injury
- Post Traumatic Stress Disorder
- Persistent Post Concussion Syndrome

## Interventions

- **OTHER:** HRV Coherence Ratio
- **BEHAVIORAL:** NSI
- **BEHAVIORAL:** Pittsburgh Sleep Quality Index (PSQI)
- **BEHAVIORAL:** Quantitative Sleep Measures
- **BEHAVIORAL:** Patient Global Impression of Change (PGIC)
- **BEHAVIORAL:** Cognitive Performance/NIH Toolbox Cognitive Battery
- **OTHER:** Pain Interference/TBI-QoL Pain Interference Short-Form
- **BEHAVIORAL:** Patient Health Questionnaire-9 (PHQ-9)
- **BEHAVIORAL:** PTSD Checklist for DSM-5 (PCL-5)
- **OTHER:** HRV Biofeedback (HRV-B)
- **OTHER:** Psychoeducational (Edu) Comparator Intervention

## Key facts

- **NCT ID:** NCT07071350
- **Lead sponsor:** Virginia Commonwealth University
- **Sponsor class:** OTHER
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-09-02
- **Primary completion:** 2028-09
- **Final completion:** 2028-09
- **Target enrollment:** 148 (ESTIMATED)
- **Last updated:** 2025-09-17

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07071350

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07071350, "Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms". Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/clinical/NCT07071350. Licensed CC0.

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