SBIR-STTR Award

The medical evaluation of patients with complaints of dizziness and disequilibrium often includes a quantitative assessment of their vestibular function. Clinically approved tests for assessing the horizontal semicircular canals currently exis (caloric testing, rotational chair testing) and a new test, crHIT, has the advantage of significanty improving resul0ts of patient evaluation compared to existing tests. However, for assessing the vertical, i.e., the anterior and posterior semicircular canals, there are currently no established tests. The Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical) has the potential to reliably assess the vertical semicircular canals and have a major impact on the management of patients with dizziness and disequilibrium. The goal of this Phase I SBIR proposal is to develop the additional hardware, analysis software, and clinical protocol necessary to adapt a commercially available clinical rotational test system, i.e., the Neuro Kinetics, Inc. (NKI) I-Portal(r) Neuro-Otologic Test Center (NOTC) for performing this new test and validating results on a limited number of subjects and vestibular patients. The long-term aim of this project is to verify the clinical efficiency of crHIT-vertical and sell this test to identify and characterize th severity of an asymmetry of vestibular function. The immediate goals of this Phase I SBIR are described by the two Specific Aims of this application. The first aim is to develop a clinical version of the crHIT-vertical: integrate all of the necessary components of hardware and software into the existing commercial rotational test system manufactured by Neuro Kinetics, (head restraint, calibration procedure for six degrees of freedom head sensor, stimulus delivery, data acquisition, and data analysis). The second aim will verify implementation of the crHIT-vertical stimulus delivery and VOR analysis software on the NKI NOTC system on 20 subjects with normal vestibular function and 20 subjects with a verified vestibular loss of vertical canals function. The tests will be performed in a clinical vestibular laboratory and will provide feedback that will be used to evaluate test comfort and to improve the user interface to the analysis software. The results from the clinical tests will be used to optimize the crHIT- vertical in advance of a Phase II SBIR test protocol.

Public Health Relevance Statement:


Public Health Relevance:
The medical evaluation of patients with complaints of dizziness and disequilibrium often includes a quantitative assessment of their vestibular function. For assessing the horizontal semicircular canals clinically approved tests (caloric testing, rotational chair testing) exist and a new test, crHIT, has the advantage of significantly improving results of patient evaluation compared to the existing tests. However, for assessing the vertical, i.e., the anterior and posterior semicircular canals, there are currently no established tests. The Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical) has the potential to reliably assess the vertical semicircular canals and have a major impact on the management of patients with dizziness and dysequilibrium.

Project Terms:
Acceleration; Anterior; Anterior semicircular canal (body structure); Calibration; Caloric Tests; Clinical; Clinical Protocols; Clinical Trials; commercialization; Communication; Computer software; computerized; Data; data acquisition; Data Analyses; design; Development; Diagnosis; Dizziness; Effectiveness; Evaluation; Eye; Eye Movements; Feedback; Freedom; Goals; Grant; Head; Head Movements; improved; Individual; Kinetics; Laboratories; Lasers; Left; Lesion; Manuals; Medical; Modification; Motion Sickness; Operative Surgical Procedures; Patients; Phase; phase 2 study; Procedures; Protocols documentation; public health relevance; Reporting; research clinical testing; restraint; Rotation; Semicircular canal structure; sensor; Severities; Small Business Innovation Research Grant; Stimulus; Structure of posterior semicircular canal; System; Testing; Time; Vestibular loss; Vestibular Neuronitis; Work

This proposal extends the proof of concept achieved in our SBIR Phase I studies. The goal of this Phase II SBIR proposal is to develop a clinically-suitable version of the hardware and software and test 120 control subjects and 66 patients to support the functionality of the vertical crHIT test for clearance by the FDA and commercial use. The immediate goals of this Phase II SBIR are described by the five Specific Aims of this application. The first aim is to build two retrofit kits for the FDA-approved I-Portal® Neuro-Otologic Test Center (NOTC) and one lower-cost, next-generation NOTC system capable of running vertical and horizontal crHIT. These systems will be installed in three Medical Centers: University of Pittsburgh Medical Center, Miami Medical Center and Mayo Clinic. The 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 VEST™ software. The third specific aim will focus on clinical testing. Total population to be enrolled in this study: 120 controls and 66 patients for a total study cohort of 186 subjects. 66 patients will include: 30 with surgically confirmed unilateral loss for validation, 15 with absent ice water calorics from vestibular neuritis, and 21 with diagnosed vestibular migraine for evaluation sensitivity and specificity of test. During clinical testing we also plan to evaluate subject's discomfort with these stimuli. The 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 symptoms. After testing and data analysis are complete we will submit results of testing to the FDA for 510K clearance (specific aim #4). FDA approval will allow us to commercially sell the vertical crHIT test to vestibular and concussion clinics. Specific aim #5 is the final report.

Public Health Relevance Statement:
Project Narrative The medical evaluation of patients with balance and equilibrium complaints requires a comprehensive assessment of the patient's vestibular function. Such an evaluation should include, for each ear, horizontal and vertical semicircular canals and both otoliths. At present there are no established tests for assessing the vertical, anterior and posterior canals. Results of our Phase I pilot study suggests the proposed computer controlled rotational Head Impulse Test vertical (crHIT-Vertical) will reliably assess the vertical semicircular canals filling a vital void in clinical practice and the management of patients with dizziness and disequilibrium.

Project Terms:
Academic Medical Centers; Anterior; Automatic Data Processing; Brain Concussion; Calibration; Clinic; Clinical; clinical practice; Clinical Protocols; Cohort Studies; Computer software; computerized; Computers; cost; Data; data acquisition; Data Analyses; Development Plans; Diagnosis; Dizziness; Ear; Effectiveness; Enrollment; Equilibrium; Evaluation; Exclusion; experimental study; FDA approved; Freedom; Goals; Goggles; Head; Ice; Laboratories; Manuals; Medical; Medical center; Methods; Migraine; Morphologic artifacts; Motion Sickness; next generation; Operative Surgical Procedures; otoconia; Patients; Phase; phase 1 study; Pilot Projects; Population; Population Control; Practice Management; Procedures; Protocols documentation; Reporting; research clinical testing; Rotation; Running; Semicircular canal structure; Sensitivity and Specificity; sensor; Small Business Innovation Research Grant; Stimulus; Symptoms; System; Technology; Test Result; Testing; Universities; Validation; Vestibular Neuronitis; Water