Implementation of a New Clinical Rotation Test of Asymmetric Vestibular Function

描述（由申请人提供）：该I期SBIR的长期目标是将一项新的正在申请专利的临床旋转测试范例整合、验证和销售到Neuro Kinetics新升级的神经-耳科测试中心，以识别和表征双耳之间前庭功能不对称的严重程度。这种新的旋转测试有可能克服旋转测试的局限性，因为它是目前实行的，并取代传统上用于识别和量化的严重程度的单侧前庭损失，冷热试验的临床测试。本申请的两个具体目标描述了第I阶段SBIR的近期目标。第一个目标是将研究实验室开发的技术转移到由Neuro Kinetics，Inc.制造的商业临床旋转测试系统，并实现适于分析由该新旋转测试诱发的前庭眼反射眼球运动的用户界面。第二个目标将通过对具有正常前庭功能的受试者和具有经验证的单侧前庭功能丧失的受试者进行有限数量的测试来验证实施。这些测试将在临床实验室环境中进行，并将提供反馈，用于评价测试舒适度和改善分析软件的用户界面。此外，最初用于开发这种新旋转测试的研究中的测试范式将得到扩展，以利用Neuro Kinetics的神经耳病学测试中心的功能。临床试验的结果将为将来II期临床试验中使用的试验组合的选择提供信息。

DESCRIPTION (provided by applicant): The long-term goal of this Phase I SBIR is to integrate, validate and sell a new patent pending clinical rotation test paradigm into Neuro Kinetics' newly upgraded Neuro-Otologic Test Center to identify and characterize the severity of an asymmetry of vestibular function between the two ears. This new rotation test has the potential to overcome the limitations of rotation testing, as it is currently practiced, and to replace the clinical test that is traditionally used to identify and quantify the severity of a unilateral vestibular loss, the caloric test. The immediate goals of this Phase I SBIR are described by the two Specific Aims of this application. The first aim is to transfer the technology developed in the research laboratory to a commercial clinical rotation test system manufactured by Neuro Kinetics, Inc., and to implement a user interface appropriate for the analysis of vestibulo-ocular reflex eye movements evoked by this new rotation test. The second aim will verify the implementation by performing a limited number of tests on subjects with normal vestibular function and subjects with a verified unilateral loss of vestibular function. The tests will be performed in a clinical laboratory setting and will provide feedback that will be used to evaluate test comfort and to improve the user interface to the analysis software. In addition, the test paradigm originally used in the research to develop this new rotation test will be extended to take advantage of the capabilities of the Neuro Kinetics' Neuro-Otologic Test Center. The results from the clinical tests will inform the selection of the test combination to be used in a future Phase II clinical trial.