SBIR-STTR Award

We plan to develop and refine a comprehensive positional management system (CPM System) for positional manifestations of vestibule disorders for widespread application at medical and research facilities. Utilizing hardware that can carry out automated positioning of the subject in a precise manner (for testing or treatment), coupled with state-of-the-art 3-D eye movement recording and analysis methods, the system will display the data, provide interpretive guidelines and assist in carrying out complex maneuvers. During phase I we will modify our prototype system these improvements to provide sophisticated motion control along 3 axes and eye movement analysis capabilities. Basic software will be developed for interactive display and control with the ability to review data from the basic management-guidance system. We will also demonstrate the value of the improved system by performing feasibility studies in a small cohort of subjects with vertigo/imbalance problems (n=20). We will validate performance by determining the added value that the CPM System brings as compared to diagnoses and treatment using the best commercially available equipment. During phase 2, we anticipate that engineering modifications will be made based upon phase 1 findings. We will also incorporate state-of-the-art systems for rotational and graviception tests; and a knowledge-based expert system. Production models will be built and installed in several beta sites for conducting human studies in a larger subject population to obtain more definitive validation and user acceptance testing.

Thesaurus Terms:
actigraphy, biomedical equipment development, body movement, eye movement computer program /software, computer system design /evaluation, infrared radiation, motion perception, space perception, vertigo bioengineering /biomedical engineering, clinical research, human subject

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.

Thesaurus Terms:
actigraphy, balance, biomedical equipment development, body movement, eye movement computer program /software, computer system design /evaluation, infrared radiation, motion perception, space perception, vertigo bioengineering /biomedical engineering, clinical research, human subject