RecruitingPhase 2Phase 3NCT07071350

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


Sponsor

Virginia Commonwealth University

Enrollment

148 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a biofeedback-based treatment (heart rate variability training) to help veterans with ongoing symptoms after a mild traumatic brain injury (concussion). The therapy trains the nervous system using breathing exercises to reduce symptoms like sleep problems, anxiety, and cognitive difficulties. **You may be eligible if...** - You are 18 or older - You have served in the military - You have had one or more mild traumatic brain injuries (concussions) - Your most recent concussion was more than 1 year ago - You still have significant persistent symptoms (scoring 20 or higher on the NSI questionnaire) - You currently have sleep difficulties - You are fluent in English **You may NOT be eligible if...** - You have never served in the military - Your most recent TBI was less than 1 year ago - You are not experiencing ongoing significant symptoms - You have conditions incompatible with the biofeedback training Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHRV Coherence Ratio

Evaluates autonomic function and the intervention process's efficacy, specifically resonance frequency breathing. The HRV Coherence Ratio will be quantified using a non-invasive procedure during resonance frequency breathing conditions and a standardized definition.

BEHAVIORALNSI

This inventory assesses the overall symptom burden, including post-concussion symptoms, on a 5-point scale. It is a well-established measure used by the Department of Defense (DoD) and VA and in mTBI outcome research at large, and includes 27 items that capture vestibular, somatosensory, cognitive, and affective symptoms.

BEHAVIORALPittsburgh Sleep Quality Index (PSQI)

It includes seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Higher PSQI scores indicate poorer sleep quality.

BEHAVIORALQuantitative Sleep Measures

Measured using wrist actigraphy, which provides objective data on sleep parameters such as sleep latency, duration, efficiency, fragmentation, and wake time after sleep onset (WASO). Participants will wear the actigraphy monitors at baseline, post-training, and follow-up assessments.

BEHAVIORALPatient Global Impression of Change (PGIC)

It evaluates patients' perceptions of clinically meaningful changes in their condition following the intervention. It is considered the gold standard for such assessments.

BEHAVIORALCognitive Performance/NIH Toolbox Cognitive Battery

Assessed using the NIH Toolbox Cognitive Battery, which measures executive function, episodic memory, working memory, processing speed, language, attention, and reading through a brief, computer-based test

OTHERPain Interference/TBI-QoL Pain Interference Short-Form

Evaluated using the TBI-QoL Pain Interference Short-Form, a 10-item questionnaire that measures the extent to which pain interferes with daily activities and overall quality of life. Each BPI-I item is scored from 0="Does not interfere" to 10="Completely interferes," and the scale score is the mean of the 7 items. Scores range from 0 to 10 with higher scores indicating greater pain interference.

BEHAVIORALPatient Health Questionnaire-9 (PHQ-9)

Assesses the severity of depressive symptoms over the past two weeks. Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.

BEHAVIORALPTSD Checklist for DSM-5 (PCL-5)

The PCL-5 (PTSD Checklist for DSM-5) is a screening tool that assesses the presence and severity of PTSD symptoms according to DSM-5 criteria. It's not a diagnostic tool itself but helps clinicians determine if further evaluation is needed. Scores range from 0 to 80, with higher scores indicating more severe symptoms.

OTHERHRV Biofeedback (HRV-B)

participants will receive weekly biofeedback training over a six-week period. Each session includes approximately 30-40 minutes of biofeedback training where participants are affixed with HRV monitoring equipment. They will be guided to synchronize their heart rate variability (HRV) through slow diaphragmatic breathing and focusing on positive emotions. This process involves viewing real-time HRV patterns on a computer monitor, with coaching to help participants achieve resonant frequency breathing.

OTHERPsychoeducational (Edu) Comparator Intervention

Six weekly meetings 30-40 minutes, viewing standardized educational content on concussion recovery. No information on breathing will be provided to participants in the Edu group.


Locations(1)

Virginia Commonwealth University

Richmond, Virginia, United States

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