Efficacy of a Virtual Reality Neuroscience-based Therapy for Chronic Low Back Pain - PROJECT SUMMARY / ABSTRACT CognifiSense has developed a unique, patented VR therapy for chronic pain, called Virtual Reality Neuroscience- based Therapy (VRNT). VRNT is specifically designed to create substantial and lasting pain reduction by targeting the centralized drivers of pain chronification and amplification. Following our highly successful Phase I study, the goal of this Phase II project is to make the VRNT system market-ready and demonstrate its efficacy in a pivotal randomized controlled trial (RCT). Phase II data will subsequently be used in an FDA submission. Chronic pain is a serious medical condition impacting an estimated 1 in 5 Americans. Chronic lower back pain (cLBP) is the most common type of chronic pain, affecting 27 million Americans. Chronic pain is a complex biopsychosocial condition with a significant centralized (central nervous system) component, which must be addressed to yield clinically meaningful, long-lasting reductions in pain. Standard treatments for cLBP yield small to medium magnitude effect sizes, and many involve risk of significant side-effects and / or addiction. Pharmacological treatments simply mask effects and do not address any underlying, centralized drivers of pain. Devices seek to address peripheral or ascending pain signals. The leading psychological therapies aim to improve primarily behavioral and emotional functioning rather than reduce pain intensity. Numerous clinical trials have shown that the effects of these treatments on pain intensity are small, and long-term effects are even more limited. Virtual reality (VR) pain therapies have shown significant promise, but most VR therapies focus on digitizing traditional psychological therapies or therapies only effective for acute pain. VRNT takes a unique approach. It uses patented technology that incorporates the latest pain neuroscience and newer, more effective psychological therapies to provide experiential learning and novel skills training to correct maladaptive neural processes. In our NIH-funded SBIR Phase I research, we established clinical proof of concept for VRNT with a small-scale randomized clinical trial of people with cLBP. The trial demonstrated that VRNT creates clinically meaningful post-treatment improvements in pain. Moreover, we generated brain imaging data that provided preliminary evidence of neuroplastic changes in the brain that paralleled chronic pain reduction from VRNT treatment. The current Phase II application will support research to make VRNT market- ready and provide pivotal data on VRNT’s placebo-controlled effect magnitude and long-term efficacy. The Specific Aims of this proposal are: 1) Port VRNT to a new VR hardware platform and make minor modifications to improve usability and engagement. 2) Develop sham VR software using an accepted sham VR design. 3) Demonstrate VRNT’s clinical efficacy and durability in people with cLBP in a sham-controlled RCT.
