SBIR-STTR Award

We plan to develop a Head-mounted Positional Management System (HPM System) for diagnosis and treatment of vestibular disorders for widespread application at medical and research facilities. Utilizing a spatial orientation sensor that can track head movement, coupled with state-of-the-art 3-D eye movement recording and analysis methods, the system will analyze eye movement (nystagmus) and spatial orientation of the head, display the data, and provide interpretive guidelines to assist the operator in carrying out complex repositioning maneuvers manually on an exam table. During Phase I we will design a wireless prototype headset combining a head-tracking system with a video nystagmus analysis and monitoring system to display graphically the ongoing spatial orientation of the subject's semicircular canals and indicate which semicircular canal is creating the nystagmus. A decision support system will offer guidance (pictorial, textual) in undertaking diagnostic and treatment maneuvers, and will monitor the precision of the user's maneuvers. We will also validate performance by demonstrating the added value of the HPM System by performing feasibility studies in a small subject cohort (n=15) with positional vertigo. We will validate performance by determining the added value of the HPM System compared to diagnosis and treatment with the best commercially available equipment. During Phase II, we anticipate that engineering modifications of the headset will be made based upon Phase I findings. Additional systems will be added to the headset, or as peripheral modules, to develop an advanced decision support system. Production models will be installed at several beta sites for conduction of human studies in a larger subject population to obtain more definitive validation and user acceptance testing.

Thesaurus Terms:
biomedical equipment development, computer assisted diagnosis, computer assisted medical decision making, computer program /software, computer system design /evaluation, head movement, proprioception /kinesthesia, vertigo balance, computer data analysis, ear disorder diagnosis, energy source, eye movement, nystagmus, semicircular duct, therapy, vestibular apparatus, video recording system adult human (21+), bioengineering /biomedical engineering, clinical research, human subject, patient oriented research

Vesticon is developing a Nystagmus-Based Repositioning (NBR) System (known in Phase I as Headmounted Positional Management System) for diagnosis and treatment of positional manifestations of vertigo for application at medical facilities. The NBR System will provide advanced, rapid analysis of nystagmus and graphic and textual guidance for carrying out repositioning maneuvers (RMs) manually on an exam table. Dizziness and balance disorders are common problems, with 6.2 million Americans chronically affected 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 accidental deaths in the elderly. The most common vestibular disorder is positional vertigo, or BPPV. Current diagnostic and treatment protocols limit optimal care and prevention of untoward consequences. Additionally, existing technology was developed before BPPV was well understood and, therefore, has limited diagnostic utility and is not designed for treatment. The NBR System will monitor spatial orientation and head/ torso motion, coupled with videographic eye movements and novel 3-D nystagmus analysis, to display data in intuitive 3-D animation, and provide guidelines for diagnostic and treatment maneuvers. Phase I goals were met or exceeded: we integrated 3-D VNG software with inertia sensors via software and hardware components and developed basic maneuver protocols and first-level guidance with interactive 3-D animation of real-time conditions. We then demonstrated clinical value of the prototype in a human feasibility study with a small subject cohort. For Phase II, we will: a) develop advanced diagnosis and treatment protocols from 1000+ database, outside expert review and beta site feedback; b) develop additional software and hardware to implement and integrate protocols, including VNG algorithm refinement, optimization and a PC hardware solution with advantages over existing vestibular technology; c) develop four beta units with wireless transmission; d) demonstrate improved clinical applications in a human study with a large subject population.

Thesaurus Terms:
biomedical equipment development, computer assisted diagnosis, computer assisted medical decision making, computer program /software, computer system design /evaluation, head movement, proprioception /kinesthesia, vertigo balance, computer data analysis, ear disorder diagnosis, eye movement, nystagmus, semicircular duct, therapy, vestibular apparatus, video recording system bioengineering /biomedical engineering, clinical research, human subject, patient oriented research