Autonomic Nervous System DiseasePhase 2/3NCT07071350
Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms
A Phase 2/3 study testing HRV Coherence Ratio, NSI and Pittsburgh Sleep Quality Index (PSQI) in people with Autonomic Nervous System Disease and Concussive Injury, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autonomic Nervous System Disease, Concussive Injury, Mild Traumatic Brain Injury
- What is being tested?
- HRV Coherence Ratio, NSI and Pittsburgh Sleep Quality Index (PSQI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to Sep 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Bret Brooks, 804-627-9692, brooksbm2@vcu.edu
Jennifer Weggen, 8046279692, weggenj@vcu.edu
About this study
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
Read the detailed description
This study, a randomized, controlled trial (RCT) of an easily implemented, mechanism-driven, behavioral intervention using HRV biofeedback (HRV-B) to treat PPCS among adults, including c-Vs and SMs, with history of single or repeated mTBI from blast-related or other mechanism. Specifically, we study an intervention for persons with PPCS that promotes sustained functional recovery during the chronic phase of injury, which addresses psychological health and cognitive functioning, and has the potential to address neurodegenerative processes associated with TBI and treat co-occurring TBI and psychological health conditions. Importantly, the intervention is non-invasive, rapidly deployable, and is based on the pathophysiology and a theoretical mechanism of PPCS. Secondarily, this project also has the potential as a more generalized solution to increase readiness and psychological resilience in individuals, small teams, families, and communities to ameliorate the potential negative impacts of specific military and life stressors.
- Conditions
- Autonomic Nervous System Disease, Concussive Injury, Mild Traumatic Brain Injury, Post Traumatic Stress Disorder, Persistent Post Concussion Syndrome
- Being tested
- HRV Coherence Ratio, NSI, Pittsburgh Sleep Quality Index (PSQI), Quantitative Sleep Measures, Patient Global Impression of Change (PGIC)
- Medical subject headings
- Brain Concussion, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV Coherence RatioOther
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.
NSIBehavioural
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.
Pittsburgh Sleep Quality Index (PSQI)Behavioural
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.
Quantitative Sleep MeasuresBehavioural
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.
Patient Global Impression of Change (PGIC)Behavioural
It evaluates patients' perceptions of clinically meaningful changes in their condition following the intervention. It is considered the gold standard for such assessments.
Cognitive Performance/NIH Toolbox Cognitive BatteryBehavioural
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
Pain Interference/TBI-QoL Pain Interference Short-FormOther
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.
Patient Health Questionnaire-9 (PHQ-9)Behavioural
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.
PTSD Checklist for DSM-5 (PCL-5)Behavioural
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.
HRV Biofeedback (HRV-B)Other
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.
Psychoeducational (Edu) Comparator InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Heart rate variability biofeedback (HRV-B) | Experimental | Behavioral intervention using HRV biofeedback (HRV-B) to treat Persistent Post-Concussion Symptoms (PPCS) among adults, including Combat Veterans (c-Vs) and Service Members (SMs), with history of single or repeated mTBI from blast-related or other mechanism. Receives: 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) |
| Education | Experimental | Psychoeducational treatment Receives: 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: Psychoeducational (Edu) Comparator Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobehavioral Symptom Inventory (NSI)
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
Measured: Baseline to end of study procedures (11 weeks)
Secondary outcomes (5)
Heart Rate Variability Biofeedback (HRV-B)
It is a biofeedback technique that trains individuals to regulate their heart rate variability (HRV) through breathing exercises. It aims to improve self-regulation, reduce stress, and enhance overall well-being by strengthening the parasympathetic nervous system. HRV varies depending on age, fitness level, and overall health, and falls between 60 and 100 ms for most individuals. However, it is important to note that a "good" HRV may differ from person to person based on their individual circumstances.
Measured: Baseline to end of study procedures (11 weeks)
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
Measured: Baseline to end of study procedures (11 weeks)
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.
Measured: Baseline to end of study procedures (11 weeks)
Patient Health Questionnaire-9 (PHQ-9)
Patient 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
Measured: Baseline to end of study procedures (11 weeks)
PCL-5 (PTSD Checklist for DSM-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.
Measured: Baseline to end of study procedures (11 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start2 Sep 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study, a randomized, controlled trial (RCT) of an easily implemented, mechanism-driven, behavioral intervention using HRV biofeedback (HRV-B) to treat PPCS among adults, including c-Vs and SMs, with history of single or repeated mTBI from blast-related or other mechanism.
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- James Burch, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071350
- Sponsor's protocol ID
- HM20031279
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms
- ClinicalTrials.gov ID
- NCT07071350
- Acronym / sponsor ID
- HM20031279
- Conditions
- Autonomic Nervous System Disease, Concussive Injury, Mild Traumatic Brain Injury, Post Traumatic Stress Disorder, Persistent Post Concussion Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study, a randomized, controlled trial (RCT) of an easily implemented, mechanism-driven, behavioral intervention using HRV biofeedback (HRV-B) to treat PPCS among adults, including c-Vs and SMs, with history of single or repeated mTBI from blast-related or other mechanism. Specifically, we study an intervention for persons with PPCS that promotes sustained functional recovery during the chronic phase of injury, which addresses psychological health and cognitive functioning, and has the potential to address neurodegenerative processes associated with TBI and treat co-occurring TBI and psychological health conditions. Importantly, the intervention is non-invasive, rapidly deployable, and is based on the pathophysiology and a theoretical mechanism of PPCS. Secondarily, this project also has the potential as a more generalized solution to increase readiness and psychological resilience in individuals, small teams, families, and communities to ameliorate the potential negative impacts of specific military and life stressors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study, a randomized, controlled trial (RCT) of an easily implemented, mechanism-driven, behavioral intervention using HRV biofeedback (HRV-B) to treat PPCS among adults, including c-Vs and SMs, with history of single or repeated mTBI from blast-related or other mechanism.
| Arm | Type | Receives |
|---|---|---|
| Heart rate variability biofeedback (HRV-B) | Experimental | 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)Behavioral intervention using HRV biofeedback (HRV-B) to treat Persistent Post-Concussion Symptoms (PPCS) among adults, including Combat Veterans (c-Vs) and Service Members (SMs), with history of single or repeated mTBI from blast-related or other mechanism. |
| Education | Experimental | 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: Psychoeducational (Edu) Comparator InterventionPsychoeducational treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV Coherence RatioEvaluates 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. | Other | Education, Heart rate variability biofeedback (HRV-B) |
| NSIThis 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. | Behavioural | Education, Heart rate variability biofeedback (HRV-B) |
| Pittsburgh 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. | Behavioural | Education, Heart rate variability biofeedback (HRV-B) |
| Quantitative Sleep MeasuresMeasured 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. | Behavioural | Education, Heart rate variability biofeedback (HRV-B) |
| Patient 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. | Behavioural | Education, Heart rate variability biofeedback (HRV-B) |
| Cognitive Performance/NIH Toolbox Cognitive BatteryAssessed 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 | Behavioural | Education, Heart rate variability biofeedback (HRV-B) |
| Pain Interference/TBI-QoL Pain Interference Short-FormEvaluated 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. | Other | Education, Heart rate variability biofeedback (HRV-B) |
| Patient 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. | Behavioural | Education, Heart rate variability biofeedback (HRV-B) |
| PTSD 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. | Behavioural | Education, Heart rate variability biofeedback (HRV-B) |
| HRV 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. | Other | Heart rate variability biofeedback (HRV-B) |
| Psychoeducational (Edu) Comparator InterventionSix 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. | Other | Education |
Primary outcome
Neurobehavioral Symptom Inventory (NSI)
Time frame: 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
5 secondary outcomes
Heart Rate Variability Biofeedback (HRV-B)
Time frame: Baseline to end of study procedures (11 weeks)
NIH Toolbox Cognitive Battery
Time frame: Baseline to end of study procedures (11 weeks)
TBI-QoL Pain Interference Short-Form
Time frame: Baseline to end of study procedures (11 weeks)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline to end of study procedures (11 weeks)
PCL-5 (PTSD Checklist for DSM-5)
Time frame: Baseline to end of study procedures (11 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Burch principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HRV Coherence Ratio, NSI and Pittsburgh Sleep Quality Index (PSQI) in people with Autonomic Nervous System Disease and Concussive Injury, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett Brooks ((804) 827-9692, bret.brooks@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobehavioral Symptom Inventory (NSI) (time frame: Baseline to end of study procedures (11 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.