The study will use Kernel FlowVR, a compact TD-fNIRS brain measurement to measure the brain-activity changes before, during, and after the use of RelieVRx
AppliedVR has teamed up with non-invasive neuroimaging provider Kernel to study the effect of AppliedVR’s RelieVRx programme on the brains of patients with chronic pain.
RelieVRx is the US Food and Drug Administration (FDA)-authorised virtual reality-based treatment for chronic lower back pain, pending FDA De Novo approval as a Class II medical device.
The study will use Kernel FlowVR, a compact TD-fNIRS brain measurement headset customised for use in VR, to investigate brain biomarkers related to RelieVRx.
Kernel Flow will measure the brain-activity changes before, during, and after the use of RelieVRx, compared to control, a VR program not designed to treat pain.
Kernel CEO and founder Bryan Johnson said: “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.”
RelieVRx is a prescription-use medical device that leverages VR content to deliver a collection of pain-management interventions.
The interventions include biopsychosocial pain education, diaphragmatic breath training, cognitive behavioural therapy, relaxation-response training, and mindfulness, among others.
The study is designed to enrol 20 patients with chronic lower-back pain, who will be randomised to receive treatment with RelieVRx and control.
The participants will undergo a pre-and post-intervention brain measurement protocol with the Kernel Flow device, which measures heart rate, respiration rate, and brain activity patterns.
The study will compare differences in brain activity for the RelieVRx group to the control group, and collect data that provides a better understanding of the effect of VR on the brain.
AppliedVR co-founder and president Josh Sackman said: “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.
“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.”
In November last year, AppliedVR received the US FDA approval for its EaseVRx, its prescription-use VR system to reduce chronic lower back pain in adults.