NEURO KINETICS, INC. — Department of Health and Human Services SBIR Phase II: NIDCD

Description

Project Title Computerized Rotational Head Impulse Test Vertical crHIT Project Summary This proposal extends the proof of concept achieved in our SBIR Phase I studiesThe goal of this Phase II SBIR proposal is to develop a clinically suitable version of the hardware and software and testcontrol subjects andpatients to support the functionality of the vertical crHIT test for clearance by the FDA and commercial useThe immediate goals of this Phase II SBIR are described by the five Specific Aims of this applicationThe first aim is to build two retrofit kits for the FDA approved I PortalNeuro Otologic Test CenterNOTCand one lower costnext generation NOTC system capable of running vertical and horizontal crHITThese systems will be installed in three Medical CentersUniversity of Pittsburgh Medical CenterMiami Medical Center and Mayo ClinicThe second specific aim will concentrate on developing a method for aligning each patient s head for testing all canals and clinical software integrated to hardware with the test protocol in the commercially available VESTsoftwareThe third specific aim will focus on clinical testingTotal population to be enrolled in this studycontrols andpatients for a total study cohort ofsubjectspatients will includewith surgically confirmed unilateral loss for validationwith absent ice water calorics from vestibular neuritisandwith diagnosed vestibular migraine for evaluation sensitivity and specificity of testDuring clinical testing we also plan to evaluate subject s discomfort with these stimuliThe focus of the current experiments will be to obtain an evaluation of general comfort level and the potential for the vertical crHIT stimuli to evoke motion sickness symptomsAfter testing and data analysis are complete we will submit results of testing to the FDA forK clearancespecific aimFDA approval will allow us to commercially sell the vertical crHIT test to vestibular and concussion clinicsSpecific aimis the final report