Implementation of a New Clinical Rotation Test of Asymmetric Vestibular Function

实施新的不对称前庭功能临床旋转测试

• 批准号: 7407021
• 负责人: ALEXANDER D KIDERMAN
• 金额: $ 10.88万
• 依托单位: NEUROLIGN USA, LLC
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-01-01 至 2009-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7407021
• 关键词: Acceleration; Adopted; Adverse effects; Adverse reactions; Air; Algorithms; Caloric Tests; Clinical; Clinical Trials; Compatible; Computer Hardware; Computer software; Data; Data Analyses; Data Collection; Data Quality; Doctor of Philosophy; Ear; Effectiveness; Ensure; External Ear; External auditory canal; Eye; Eye Movements; Feedback; Future; Generations; Goals; Grant; Head; Health Sciences; Hospitals; Irrigation; Judgment; Kinetics; Knowledge; Laboratories; Laboratory Research; Legal patent; Lesion; Methods; Modification; Motion; Motion Sickness; Nausea; Numbers; Oregon; Phase; Phase II Clinical Trials; Physiology; Positioning Attribute; Preparation; Procedures; Protocols documentation; Range; Reflex eye movement; Research; Rotation; Running; Sampling; Semicircular canal structure; Severities; Side; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Stimulus; System; Technology Transfer; Testing; Time; United States National Institutes of Health; Universities; Vestibular Function Tests; Vestibular loss; Water; design; implementation research; improved; receptor; research clinical testing; research study; systems research; user-friendly; vestibulo-ocular reflex

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.

描述(由申请人提供)：该第一阶段SBIR的长期目标是将正在申请专利的新的临床旋转测试范例整合、验证并销售到Neuro Kinetics新升级的神经耳科测试中心，以识别和表征两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目前正在进行的旋转测试的局限性，并取代传统上用于识别和量化单侧前庭丧失的严重程度的临床测试，即冷热测试。本申请的两个具体目标描述了第一阶段SBIR的直接目标。第一个目标是将研究实验室开发的技术转移到Neuro Kinetics公司制造的商业临床旋转测试系统上，并实现一个适合分析由这种新的旋转测试引起的前庭-眼睛反射眼球运动的用户界面。第二个目标将通过对前庭功能正常的受试者和被证实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情况。这些测试将在临床实验室环境中进行，并将提供反馈，用于评估测试舒适度和改进分析软件的用户界面。此外，最初用于研究开发这种新的旋转测试的测试范式将被扩展，以利用Neuro Kinetics的神经耳科测试中心的能力。临床测试的结果将为未来第二阶段临床试验中使用的测试组合的选择提供信息。