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AppliedVR and Kernel Flow Announce Clinical Results Evaluating How Brain Changes During Virtual Reality Treatment of Chronic Pain


New feasibility study indicates that VR has the potential to drive physiological changes in the body and brain associated with pain relief


LOS ANGELES, Feb. 8, 2024 /PRNewswire/ -- AppliedVR®, a medical device pioneer advancing a novel, virtual reality-based approach to medicine, and Kernel today announced a joint study measuring the impact of VR pain treatment on the brain. The study, which included a single-blind, sham-controlled design, compared brain activation patterns and physiological metrics before, during, and after VR experiences in people experiencing chronic low back pain (CLBP).


The research used AppliedVR's RelieVRx® medical device, an eight-week, skills-based program that helps chronic low back pain (CLBP) patients learn self-management skills, combined with Kernel Flow and FlowVR—a compact, affordable, TD-fNIRS brain measurement headset customized for use in VR—to measure brain hemodynamic changes associated with pain relief.


While participants in the RelieVRx and sham groups both experienced varying levels of pain relief after completing the eight-week treatment, researchers determined that participants in the RelieVRx group experienced enhanced brain activation coherence -- change that previously has been related to reduced pain -- from pre-to-post treatment. Those patients receiving the VR sham control demonstrated a decline in brain coherence. Additionally, those receiving treatment from the RelieVRx device achieved a slower breathing rate as compared to the sham VR group. These results suggest that active RelieVRx treatment can create physiological changes in the body and have an impact on coherent global brain activity.


Pain is subjective and hard to measure outside of patient-reported outcomes, but affordable and accessible brain imaging could help researchers and providers better understand a patient's level of pain and the impact of an intervention. AppliedVR and Kernel plan to conduct clinical studies to uncover how RelieVRx as an intervention could drive certain physiological changes in breathing and brain patterns that have been linked to pain relief.


"We're committed to developing a significant body of scientific evidence that demonstrates how our RelieVRx program, which is rooted in self-regulation, cognitive behavioral therapy skills and mindfulness, engages the brain and can impact the experience of pain," said AppliedVR Co-founder and President Josh Sackman. "While we know there can be a strong placebo effect, this feasibility study showed that only the active RelieVRx treatment created changes at a physiological and brain activity level, creating a strong foundation for future research."


Chronic pain costs the U.S. an estimated $635 billion each year and is a major contributing factor driving America's opioid crisis. Research has suggested that more than 72 million Americans suffer from chronic low back pain, with the condition being a leading cause of disability.


"This exciting research shows how our Kernel Flow technology can measure the brain and help quantify notoriously difficult to measure conditions," said Kernel CEO Ryan Field. "By unlocking insights into specific biomarkers related to chronic pain, we can continue to help the medical community better understand how treatments like RelieVRx can change the practice of pain medicine."


This study is part of an ongoing collaboration between AppliedVR and Kernel. Both organizations will continue to deepen and expand their research to larger and more diverse populations.


About AppliedVR

AppliedVR is creating a new reality in healthcare. We are pioneering immersive therapeutics (ITx), a new category of medicine, to treat intractable health conditions that affect millions of people worldwide. Today, AppliedVR's treatments represent a robust approach to chronic lower back pain (CLBP) that empowers patients with an intuitive device they can self-manage at home. AppliedVR's RelieVRx® program is the first VR-based, prescription therapeutic to receive Breakthrough Device Designation and De Novo authorization by the FDA for CLBP. AppliedVR's wellness programs have been trusted by more than 200 leading health systems and thousands of healthcare professionals globally, used on more than 60,000 patients. For more information, visit www.appliedvr.io.


About Kernel

Kernel is dedicated to advancing precision medicine through neurotechnology. Validated through multiple peer-reviewed publications, Kernel's tech builds on decades of neuroimaging advances. Kernel's next-generation neuroimaging platform for measuring brain-based biomarkers can be used to accelerate treatment development, improve patient outcomes, and reduce healthcare costs. Current trials are underway to predict patient response to depression treatments and develop brain-based biomarkers of mild cognitive impairment.


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