SBIR/STTR Award attributes
Soldiers displaying symptoms of mild traumatic brain injury (mTBI) need accurate, timely, in-theater assessment of their symptoms. Often, initial assessment and diagnosis must be conducted by first-level responders who attempt to assess vestibular symptoms directly following a concussive event; however, symptoms or indicators are often missed, not adequately evaluated, or misdiagnosed due to a lack of familiarity with the subtleties of impaired vestibular function. First responders need a reliable, easy-to-use, lightweight system for supporting simple and repeatable mTBI assessments, and making return-to-duty (RTD) decisions. During our successful Phase I and Phase II Assessment and Diagnosis of Vestibular Indicators of Soldiers’ Operational Readiness (ADVISOR) effort, Charles River Analytics developed a TRL 4 prototype system designed to facilitate the administration of a series of clinically validated assessments of gaze stability and static and dynamic postural stability, translated for deployment using only a smartphone application and a virtual reality (VR) head-mounted display (HMD) with an adjoining computing platform. ADVISOR is a patent-pending (62/373,083; PCT/US2017/¬046266) solution that addresses the challenges of in-theater mTBI screening to promote more appropriate RTD decisions. Through multiple Government- and internally-funded development efforts, we have developed the next evolution of ADVISOR hardware—now consisting of full commercial off the shelf hardware, including a lightweight and rugged VR HMD with integrated eye tracking and an extremely small form factor embedded computing solution. The ADVISOR software guides medical responders (e.g., Army Medics, Navy Corpsmen) to consistently administer assessments and correctly interpret the results via an intuitive workflow and model-based mTBI classification. In a second Phase II effort, we will (1) evaluate the hardware and software interfaces for usability and ergonomics, (2) expand and refine the hardware components of ADVISOR to incorporate recent developments in HMD and application and new usability considerations, (3) validate diagnostic efficacy by evaluating ADVISOR’s assessment with healthy and mTBI cohorts, and (4) continue refined system evaluations with the Sponsor, transition partners, and commercial partners, and begin planning and execution of an FDA strategy to bring the device to market.
