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Efficacy of a Virtual Reality Neuroscience-based Therapy for Chronic Low Back Pain

Award Number: R44NR017575
ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/23/2019
PERIOD OF PERFORMANCE END DATE: 04/30/2027

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $406,285 )
2026	2026	COGNIFISENSE, INC.	1271 LAKESIDE DR	SUNNYVALE	CA	94085	SANTA CLARA	USA	Nursing Research	001	4	5/7/2026	NON-COMPETING CONTINUATION	$406,285
2026	2026	COGNIFISENSE, INC.	1271 LAKESIDE DR	SUNNYVALE	CA	94085	SANTA CLARA	USA	Nursing Research	002	4	8/4/2026	NON-COMPETING CONTINUATION	$0
2026	2025	COGNIFISENSE, INC.	1271 LAKESIDE DR	SUNNYVALE	CA	94085	SANTA CLARA	USA	Nursing Research	000	3	4/28/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $406,285

Issue Date FY: 2025 ( Subtotal = $580,584 )
2025	2025	COGNIFISENSE, INC.	1271 LAKESIDE DR	SUNNYVALE	CA	94085	SANTA CLARA	USA	Nursing Research	000	3	4/16/2025	NON-COMPETING CONTINUATION	$580,584
														Subtotal = $580,584

Issue Date FY: 2024 ( Subtotal = $977,764 )
2024	2024	COGNIFISENSE, INC.	1271 LAKESIDE DR	SUNNYVALE	CA	94085	SANTA CLARA	USA	Nursing Research	001	2	7/15/2024	COMPETING CONTINUATION	$0
2024	2024	COGNIFISENSE, INC.	1271 LAKESIDE DR	SUNNYVALE	CA	94085	SANTA CLARA	USA	Nursing Research	002	2	8/27/2024	COMPETING CONTINUATION	$0
2024	2024	COGNIFISENSE, INC.	1271 LAKESIDE DR	SUNNYVALE	CA	94085	SANTA CLARA	USA	Nursing Research	000	2	6/11/2024	COMPETING CONTINUATION	$977,764
														Subtotal = $977,764

Grand Total All Awards = $1,964,633

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Efficacy of a Virtual Reality Neuroscience-based Therapy for Chronic Low Back Pain

Award Number: R44NR017575

ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/23/2019

PERIOD OF PERFORMANCE END DATE: 04/30/2027

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