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

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment aimed at improving heart rate variability (HRV) to help people who continue to experience symptoms long after a mild traumatic brain injury, such as a concussion. These ongoing symptoms—called persistent post-concussion symptoms—can include headaches, dizziness, trouble thinking or remembering, sleep problems, and mood changes like irritability or depression. The study focuses on veterans and service members who have had at least one mild brain injury more than a year ago and are still dealing with significant symptoms that affect their daily lives. Researchers believe that problems with the autonomic nervous system, which controls things like heart rate and stress responses, may be keeping these symptoms going, and improving HRV could help.

If you are 18 or older, have served in the military, and have had a mild brain injury with ongoing symptoms like sleep difficulties, you might be eligible to join. Participants will be asked to take part in the treatment and monitoring, which involves measuring heart rate changes over time to see if the therapy helps improve symptoms. The study is currently recruiting adults of all genders who speak English and can provide informed consent. People with more severe brain injuries, certain heart conditions or devices, a history of stroke, or mental health issues that could make it hard to follow the study plan are not eligible. This trial offers a chance to explore a new way to manage long-lasting effects of concussion, especially in those who have served in the military.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age 18 or older
• • History of military service
• • Self-Reported hx of 1 or more mild TBI
• • Most recent TBI more than 1 year ago
• • Significant Persistent Post-Concussion Symptom burden (Neurobehavioral Symptom Inventory \[NSI\] total score greater than or equal to 20).
• • Current Sleep Difficulties
• • Fluent English
• • Able to provide Informed Consent
• Exclusion Criteria:
• • Any TBI with severity greater than mild (i.e., Moderate or Severe TBI defined as initial injury loss of consciousness (LOC) duration \>30 minutes, posttraumatic amnesia (PTA) duration \>24 hours, or traumatic hemorrhage on head computerized tomography (CT) and determined by the study investigator based on information gathered during administration of the study's validated TBI structured interview instrument.
• • Conditions or medications that can affect HRV measurement (pacemaker or an implant that stimulates your heart (e.g., cardioverter-defibrillator or ICD); heart transplant or heart surgery within the last year, including bypass or other surgery, but not including a stent)
• • Hx of stroke
• • Mental conditions that may impede adherence (e.g., dementia, psychotic disorder, panic disorder)