AppliedVR, a pioneer in immersive digital therapeutics, and Kernel, a leader in non-invasive neuroimaging, announced a joint randomized study comparing the effect of AppliedVR’s FDA-authorized, VR-based program, RelieVRx, versus a control (VR program not designed to treat pain) on the brains of patients with chronic pain. The study will use Kernel FlowVR—a compact, affordable, TD-fNIRS brain measurement headset customized for use in VR—to investigate brain biomarkers associated with RelieVRx.

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Kernel FlowVR Neuroimaging Technology (Photo Credit: Kernel)

AppliedVR’s RelieVRx is a prescription-use medical device which uses VR content to deliver a suite of pain-management interventions rooted in biopsychosocial pain education, diaphragmatic breath training, cognitive behavioral therapy, relaxation-response training, mindfulness and more. Kernel Flow’s ability to measure brain-activity changes before, during, and after VR use will enable high-quality objective data.

This study will examine the effect of the AppliedVR software modules and the 8-week training program on chronic pain patients through the measurement of heart-rate, respiration-rate, and brain activity patterns using the Kernel Flow device. The study will enroll 20 patients with chronic lower-back pain randomized into treatment and control groups, who will undergo a pre- and post-intervention brain measurement protocol with Kernel Flow. The goal is to evaluate quantifiable differences in measured brain activity for the RelieVRx group versus the control group, and collect biodata to better understand how VR engages the brain.

In the U.S., approximately 12% of all adults experience chronic lower-back pain⁽¹⁾. A 2020 study in the Journal of American Medical Association found that costs associated with lower-back and neck injury topped $134B, making it the highest-cost category of health spending in the country.

“Kernel Flow allows for a safe, natural, and comfortable brain-imaging experience. Our partnership with AppliedVR is an exciting opportunity to use Kernel Flow’s revolutionary technology to illuminate and unlock insight on specific biomarkers related to chronic pain, one of the most debilitating and costly medical conditions in our healthcare system. These biomarker-based insights may someday be used to evaluate the effectiveness of treatments and personalize them to individuals,” said Kernel CEO and founder Bryan Johnson.

“AppliedVR is committed to being the most evidence-based immersive therapeutics provider in the world, which means we are constantly looking for smarter, more in-depth ways to not only demonstrate that the RelieVRx system delivers durable pain relief, but also to understand how it works on the brain,” said Josh Sackman, cofounder and president of AppliedVR. “As an industry leader, Kernel’s FlowVR technology was the right partner for us to begin to better understand how VR affects the brain’s responses to pain, and we look forward to continuing our research.”

About AppliedVR

AppliedVR is pioneering evidence-based, immersive VRx — a new category of prescription digital therapeutics — that includes RelieVRx, the first virtual reality-based treatment for chronic lower back pain to be granted a FDA De Novo request as a Class II medical device. Backed by an unparalleled body of evidence, AppliedVR's mission is to solve pain through immersive therapeutics with the ultimate goal of a virtual reality pharmacy in every home. By developing the infrastructure and partnerships necessary to transform the pain treatment paradigm, AppliedVR empowers patients to live life — beyond chronic pain. Trusted by more than 200 of the world's leading health systems and thousands of healthcare professionals globally, AppliedVR's immersive therapeutics have been used by approximately 60,000 patients to date in pain management and wellness programs. For more information, visit www.appliedvr.io.

About Kernel Flow

Kernel Flow is a wearable headset that measures brain activity by recording local changes in blood oxygenation. It is adjustable, can accommodate nearly anyone and is safe. Kernel Flow is a groundbreaking neurotechnology because it reduces loud, expensive, and room-sized equipment to a head-worn apparatus while providing neural activity data of the highest possible optical quality. This combination has never existed in such a commercial and scalable device, all factors for why brain interfaces and neuroimaging technology has largely remained in academic labs or hospital basements. The entire system is portable and, in the future, will be more broadly used for neuroscientific or physiological studies of brain activity during treatment.

¹ https://onlinelibrary.wiley.com/doi/abs/10.1002/art.34347

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