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 这项建议扩展了我们在SBIR第一阶段研究中所取得的概念证明。这一阶段的目标是 SBIR的建议是开发临床适用的硬件和软件版本，并测试120控制 受试者和66名患者支持垂直crHIT测试的功能，以获得FDA和 商业用途。第二阶段SBIR的近期目标由五个具体目标描述 申请。第一个目标是为FDA批准的i-Portal®神经耳科测试中心制造两个改装套件 (NOTC)和一个低成本、能够运行垂直和水平crHIT的下一代NOTC系统。 这些系统将安装在三个医学中心：迈阿密匹兹堡大学医学中心 医疗中心和梅奥诊所。第二个具体目标将集中在开发一种对齐方法 用于测试所有管路的每个患者的头部和集成到硬件中的临床软件和测试协议 商用的VEST™软件。第三个具体目标将集中在临床测试上。总计 纳入这项研究的人群：120名对照组和66名患者，共186名受试者。66 患者将包括：30例经手术证实的单侧丢失进行验证，15例缺乏冰水卡路里。 来自前庭神经炎，以及21例诊断为前庭偏头痛的患者，评估其敏感性和特异性 测试。在临床测试中，我们还计划评估受试者对这些刺激的不适感。这次会议的重点是 目前的实验将获得对总体舒适度和垂直方向潜力的评估 刺激引起晕动病症状。在测试和数据分析完成后，我们将提交 向FDA提交510K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 将垂直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.