Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical)

项目名称 计算机化旋转头部冲击试验-垂直crHIT 项目摘要 该提案扩展了我们SBIR第一阶段研究中实现的概念验证。第二阶段的目标是 SBIR的建议是开发一个临床适用的硬件和软件版本，并测试120控制 受试者和66名患者，以支持垂直crHIT测试的功能，以获得FDA的批准， 商业用途。本SBIR第II阶段的近期目标由本SBIR的五个具体目标描述。 应用程序.第一个目标是为FDA批准的I-Portal®神经耳科测试中心建立两个改造套件 （NOTC）和一个成本更低，下一代NOTC系统能够运行垂直和水平crHIT。 这些系统将安装在三个医疗中心：匹兹堡大学医学中心，迈阿密 医疗中心和马约诊所。第二个具体目标将集中于开发一种方法， 每个患者的头部，用于测试所有管道和集成到硬件的临床软件， 市售的VEST™软件。第三个具体目标将侧重于临床试验。总 本研究入组的人群：120例对照和66例患者，共186例受试者的研究队列。66 患者将包括：30例经手术证实的单侧失能患者，15例无冰水热量的患者 前庭神经炎和21例诊断为前庭性偏头痛的患者， test.在临床测试期间，我们还计划评估受试者对这些刺激的不适。的重点 目前的实验将获得一般舒适水平的评价和垂直的潜力， crHIT刺激诱发晕动病症状。测试和数据分析完成后，我们将提交 向FDA提交510 K许可的测试结果（具体目标#4）。FDA的批准将允许我们在商业上 把垂直crHIT测试卖给前庭和脑震荡诊所具体目标#5是最终报告。

Project Title Computerized Rotational Head Impulse Test-Vertical crHIT Project Summary 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.