VRMC expects to be the first to market with an FDA-cleared medical device using virtual reality (VR) pain management software. Brain imaging shows that being distracted has a real effect in decreasing the intensity of pain signals in the brain. Virtual reality is a more immersive experience than other forms of distraction, and preliminary research indicates that VR actually changes how the brain physically registers pain, not just people’s perception of the incoming signals. Under U.S. government R&D contracts, VRMC has designed and tested its device, showing that VRMC products reduce pain by 75%.
NIDA Burn/Pain Distraction
NIDA VR for Burn Pain Distraction
Participants in the Phase I study were 6 volunteers (2 women, 4 men) recruited from the patient population at Naval Medical Center San Diego (NMCSD). All 6 participants reported a drop in pain while in the VR environment, and the magnitude of pain reduction from the VR compared to the pain focus condition was large (75.8%) and significant. All of the participants reported lower pain ratings while engaged in South Pole Fantasy. A pain rating of 0 was reported by 4 of the 6 participants for the South Pole Fantasy session. A nonparametric Wilcoxon signed rank test indicated that the mean pain rating during the South Pole Fantasy condition was significantly lower than the session with no distraction (n = 6; p = 0.028).
The planned Phase II project will expand upon these results by conducting a controlled study with 180 patients at 6 sites in 4 countries. Participants will receive standard treatment (ST) for half of 3, 30-minute pain care sessions and ST with VR (randomized to head-mounted display [HMD] or flat-panel display [FPD]) for the other half of the sessions. We will test if 1) participants, when exposed to an interactive VR environment during ST, will report a decrease in self-reported anxiety and pain compared to ST alone, 2) participants in the more immersive HMD group will experience greater reduction in pain and anxiety than participants in the FPD group, 3) psychological factors such as quality of life and depression will be improved by the VR treatment, and 4) the immersive HMD group will exhibit a greater reduction in depression levels compared to the FPD group. Exploratory hypotheses address maintenance of treatment effects across sessions, effectiveness of VR for both chronic and acute pain distraction, and uniform results across cultural boundaries. The study protocol is registered at ClinicalTrials.gov.
In 2006, VRMC applied for and won the right to present at the Keiretsu Forum, an investment community of accredited private equity investors, venture capitalists, and corporate/institutional investors. The VRMC product was highlighted via 4 formal and 2 informal presentations throughout Southern California in August 2006. In September 2006, VRMC was chosen as a finalist in the medical device technology category for the AeA High Tech Award (San Diego Council), and won UCSD CONNECT Springboard assistance. Also in September 2006, VRMC won a second year of commercialization support for its pain management products from the National Institutes of Health Commercialization Assistance Program (NIH-CAP).
In January 2007, as a result of VRMC’s commercialization efforts related to its pain management products, VRMC received a recommendation for ISO 9001:2000 and ISO 13485:2003 certification. For presentation of its cell phone VR pain management product to investors at the Larta Institute’s Venture Forum May 1–2, 2007 in San Francisco, VRMC won Best in Show.
VRMC applied for and won the right to present “Pain Distraction Software for Mobile Platforms” on May 24, 2007 at the TechConnect Summit 2007 in Santa Clara, CA, a venue at which VRMC was also able to exhibit its mobile pain management software during the May 23, 2007 Global Technology Showcase Reception.
On June 29, 2007, after months of preparation guided by the CONNECT Springboard advisors, VRMC presented the cell phone pain management product to a group of investors. In July 2007, VRMC’s Springboard participation prompted both a media interview that may be used in German business magazine Brand Eins and an invitation to speak at the CONNECT Board of Directors meeting.
NIDA Dental/Pain Distraction
NIDA VR for Pain Distraction during Dental Procedures
The objective was to test use of a custom-designed VR environment’s effectiveness in distracting from the pain of dental procedures. No VR pain distraction product customized to dental practice currently exists. The Phase III product, a fully integrated VR and physiological monitoring device for use in general dental practice, will consist of virtual environment software, compatible computer hardware, a head-mounted display (HMD), physiological sensors, a physiological sensor interface module, and a wireless peripheral device used to interact with and explore the virtual world. The system is designed to be inexpensive, easy to use, upgradeable, and reliable. Analysis of human factors is focusing on the unique aspects of care delivery in the modern dental suite.
VRMC placed another of its pain distraction virtual environments for testing at Naval Medical Center San Diego (NMCSD), where a culturally diverse population suffers from chronic pain from disorders such as fibromyalgia, lower back pain, migraine, and temporomandibular joint dysfunction. NMCSD also treats active duty military returning from Operation Iraqi Freedom who have shrapnel and burn wounds and are experiencing acute pain. The NMCSD clinical study found that this virtual environment, navigated using an HMD, dramatically reduced pain ratings by over 75 percent. Physiological data collected from this same population corroborated this discovery and suggests that participants experienced less anxiety while engaged in the virtual world.
Because of its work with NIH, VRMC is required to be certified by the U.S. Office of Public Health and Science, Office of Research Integrity. All VRMC research staff possess certificates of completion for the HHS Office of Human Research Protections Human Subject Assurance Training, and the National Cancer Institute’s Human Participant Protections Education for Research Teams.
In 2005, Dr. Mark Wiederhold won the opportunity to showcase the “Dental II Results” poster presentation at the 7th Annual NIH SBIR/STTR Conference, July 28-29, in Washington, DC. Next, VRMC won 1 year of commercialization support for its pain management products from the National Institutes of Health Commercialization Assistance Program NIH-CAP), beginning September 2005. In October 2006, VRMC was invited to speak about its experience in this program at the NIH-CAP Commercialization Training Workshop. Finally, VRMC was invited to exhibit its pain and PTSD products at the California Early Stage Medical Device Company Showcase, part of the California Medical Device Forum held November 1-2 in Irvine.
VRMC’s dental product was featured in the peer-reviewed journal Pain Medicine (Wiederhold, M.D., & Wiederhold, B.K. (2007). Virtual reality and interactive simulation for pain distraction. Pain Medicine, 8(S3), S182–S188).