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.