Study for Persistent Post-Concussion Symptoms Using HRV Biofeedback

This study is testing a behavioral intervention called HRV biofeedback (HRV-B) to help people with persistent post-concussion symptoms (PPCS). PPCS are lasting problems like headaches, dizziness, and memory issues that can happen after a mild traumatic brain injury (concussion). The study aims to see if HRV-B, which helps regulate your body's automatic functions (autonomic nervous system), can improve these symptoms. We are looking for adults aged 18 or older with a history of military service and at least one mild TBI that happened over a year ago. You should also have significant ongoing post-concussion symptoms, measured by a score of 20 or higher on the Neurobehavioral Symptom Inventory (NSI). The main goal is to see how much your NSI score changes from the beginning to the end of the study, which is about 11 weeks. The current status of the study is unclear.

Study design
This is a randomized controlled trial planning to enroll 148 participants. It compares the HRV Coherence Ratio intervention with other assessments.
What's involved
You will undergo assessments including the Neurobehavioral Symptom Inventory (NSI), Pittsburgh Sleep Quality Index (PSQI), and Patient Global Impression of Change (PGIC). You will also wear a wrist actigraphy monitor at the start, after training, and at follow-up to measure sleep.
Compensation
Not stated in the trial record.
Follow-up
Your Neurobehavioral Symptom Inventory (NSI) will be measured from the start of the study until the end of study procedures, which is 11 weeks.

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NCT07071350

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Virginia Commonwealth University
~148 participants
Updated 2025-09-17 on ClinicalTrials.gov
What's tested:HRV Coherence RatioNSIPittsburgh Sleep Quality Index (PSQI)Quantitative Sleep MeasuresPatient Global Impression of Change (PGIC)Cognitive Performance/NIH Toolbox Cognitive Battery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurobehavioral Symptom Inventory (NSI)
Measured over Baseline to end of study procedures (11 weeks)
Autonomic Nervous System Disease
Concussive Injury
Mild Traumatic Brain Injury
Post Traumatic Stress Disorder
Persistent Post Concussion Syndrome
1 sites across 1 states
Virginia1
  • James Burch · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

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Eligibility criteria

Inclusion

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

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)
  • Neurobehavioral Symptom Inventory (NSI)Baseline to end of study procedures (11 weeks)

    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