HRV Biofeedback for Post-Concussion Syndrome

Overseen By Jennifer Weggen

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Virginia Commonwealth University

Disqualifiers: Moderate/severe TBI, Stroke, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 11 weeks

148 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if heart rate variability biofeedback (HRV-B) can improve physical and mental well-being in individuals with persistent post-concussion symptoms (PPCS). PPCS can lead to headaches, dizziness, memory problems, and irritability. The trial will compare HRV-B, which focuses on controlling heart rhythms to enhance health, with educational support. It seeks military veterans and service members who experienced a mild concussion over a year ago and continue to face symptoms like sleep difficulties. As a Phase 2 and Phase 3 trial, this research evaluates the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on medications that can affect heart rate variability measurements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that HRV biofeedback is generally safe and well-tolerated. Previous studies found that it can improve brain function and help balance the autonomic nervous system, which controls heart rate and digestion. These studies did not report any serious side effects, suggesting the treatment is safe for most people. As this trial is in later stages, evidence already supports the safety of HRV biofeedback for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about HRV biofeedback for Post-Concussion Syndrome because it offers a new approach compared to typical treatments like medication and cognitive therapy. Unlike standard methods that mainly focus on symptom management, HRV biofeedback uses a behavioral intervention to help patients gain control over their heart rate variability, which can improve autonomic nervous system function. This method is particularly promising for those with Persistent Post-Concussion Symptoms, as it provides a non-invasive, self-regulating way to potentially alleviate symptoms. Additionally, there's an experimental arm focusing on psychoeducation, which aims to empower patients with knowledge and coping strategies. With its innovative approach and potential for self-management, this trial could offer new hope for those struggling with the long-term effects of concussions.

What evidence suggests that HRV biofeedback is effective for post-concussion syndrome?

Research has shown that Heart Rate Variability Biofeedback (HRV-B), which participants in this trial may receive, can help treat ongoing symptoms after a concussion. After ten weeks of HRV-B training, patients demonstrated noticeable improvement in heart rate variability, indicating better heart rhythm and emotional well-being. Studies also find that HRV-B helps balance the body's autonomic nervous system, reducing symptoms like headaches and dizziness. This suggests that HRV-B holds promise for those dealing with the lasting effects of a concussion. ^{1 2 3 4 6}

Who Is on the Research Team?

James Burch

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for combat veterans, service members, and civilians who have had a mild traumatic brain injury (concussion) and are experiencing ongoing symptoms like headaches, dizziness, memory issues, or mood changes. Participants should be suffering from these post-concussion symptoms that affect their well-being.

Inclusion Criteria

Self-Reported history of 1 or more mild TBI

Fluent English

Able to provide Informed Consent

Exclusion Criteria

Mental conditions that may impede adherence (e.g., dementia, psychotic disorder, panic disorder)

I have had a stroke in the past.

I have had a moderate or severe traumatic brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HRV biofeedback and psychoeducational treatment to optimize heart rate variability for persistent post-concussion symptoms

11 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HRV Biofeedback

Trial Overview The study tests if improving heart rate variability (HRV), which reflects autonomic nervous system health, can help with persistent post-concussion symptoms. It involves HRV biofeedback training compared to an educational intervention on the condition.

How Is the Trial Designed?

Group I: Heart rate variability biofeedback (HRV-B) Experimental Treatment 10 Interventions

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.

Group II: Education Experimental Treatment 10 Interventions

Psychoeducational treatment

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10582136/

Heart Rate Variability Biofeedback for Mild Traumatic Brain ... After ten weeks of HRV-BF training, the patient showed a significant increase in HRV and improvement in cardiovagal activity, as well as a reduction in mood ...

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/20597002211046459

Biofeedback as an intervention for persistent post- ... Case reports indicate that low-resolution electromagnetic tomography neurofeedback and heart rate variability biofeedback may improve physiological functioning

3. researchgate.net researchgate.net/publication/273987261_Heart_Rate_Variability_Biofeedback_for_Postconcussion_Syndrome_Implications_for_Treatment

Heart Rate Variability Biofeedback for Postconcussion ... The authors hypothesize that HRV biofeedback training will ameliorate PCS by improving autonomic balance as well as cerebral autoregulation.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07071350

NCT07071350 | Randomized Controlled Trial of Treatment ... Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms. ClinicalTrials.gov ID NCT07071350.

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2014.00890/full

Heart rate variability interventions for concussion and ... At the end of treatment, the patient showed greater HRV, and greater LF power, as well as significant reduction in severity of post-concussion headaches and ...

6. withpower.com withpower.com/trial/phase-2-and-3-autonomic-nervous-system-diseases-7-2025-14a10

HRV Biofeedback for Post-Concussion Syndrome Participants receive HRV biofeedback and psychoeducational treatment to optimize heart rate variability for persistent post-concussion symptoms. 11 weeks.