Comprehensive Positioning Management System

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DESCRIPTION (provided by applicant): Vesticon, Inc. is developing a comprehensive evaluation and management system for positional manifestations of vestibular disorders (Comprehensive Positional Management System) (CPM System) for application at medical and research facilities. Dizziness and balance disorders are among the most common problems in US healthcare, with 6.2 million chronically affected Americans between ages 40 and 69, and a majority of those over age 70 reporting balance problems, where balance-related falls account for more than half of the accidental deaths in the elderly. The most common vestibular disorder is Benign Paroxysmal Positional Vertigo (BPPV). Currently available diagnostic and patient care management protocols limit optimal medical care and prevention of untoward consequences, including falls in the elderly. In addition, existing medical technology was developed before BPPV was well understood, and is therefore limited in diagnostic utility and not optimal, nor cleared by the FDA, for treatment. The proposed CPM System will utilize technology that can safely carry out automated positioning and positional maneuvers in patients with BPPV and variants. It will do so in all three rotational dimensions, and, coupled with 3-D recordings, will permit quantitative and consistent evaluation and treatment of patients with the most common causes of balance problems. Recently, Phase I work for the re-engineering of the prototype multi-axial chair was completed, where 3-D motion control and an additional 3-D eye movement analysis system were integrated with basic software components for interactive display and control. All Phase I goals were met or exceeded. During Phase II, we will develop: a) protocols for diagnosis, treatment and follow-up monitoring using the original prototype's 1000+ patient records in consultation with independent expert review, and subject to evidence-based methodology; b) software to implement protocols, graphical user interfaces, printed reports and data storage/retrieval and expert decision-support system; c) user-selectable levels of automation of maneuvers recommended by the decision support system; and d) a lighter, transportable production model of the CPM System hardware. Finally, we will demonstrate improved clinical applications at the Pl's clinic and three independent beta sites to carry out human studies in a large subject population.