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

计算机化旋转头脉冲测试 - 垂直 (crHIT-vertical)

• 批准号: 9567463
• 负责人: ALEXANDER D KIDERMAN
• 金额: $ 51.51万
• 依托单位: NEUROLIGN USA, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9567463
• 关键词: Academic Medical Centers; Anterior; Automatic Data Processing; Brain Concussion; Calibration; Clinic; Clinical; Clinical Protocols; Cohort Studies; Computer software; Computers; Data; Data Analyses; Development Plans; Diagnosis; Dizziness; Ear; Effectiveness; Enrollment; Equilibrium; Evaluation; Exclusion; FDA approved; Freedom; Goals; Goggles; Head; Ice; Laboratories; Manuals; Medical; Medical center; Methods; Migraine; Morphologic artifacts; Motion Sickness; Operative Surgical Procedures; Patients; Phase; Pilot Projects; Population; Population Control; Practice Management; Procedures; Protocols documentation; Reporting; Rotation; Running; Semicircular canal structure; Sensitivity and Specificity; Small Business Innovation Research Grant; Stimulus; Symptoms; System; Technology; Test Result; Testing; Universities; Validation; Vestibular Neuronitis; Water; clinical practice; computerized; cost; data acquisition; experimental study; next generation; otoconia; phase 1 study; research clinical testing; sensor

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.

项目标题 计算机旋转头脉冲测试 - 垂直CRHIT 项目摘要 该建议扩展了我们SBIR I期研究中获得的概念证明。这一阶段的目标 SBIR建议是开发硬件和软件的临床适合版本，并测试120控制 受试者和66名患者支持垂直CRHIT测试的功能，以通过FDA和 商业用途。该第二阶段SBIR的直接目标是由五个具体目的描述的 应用。第一个目的是为FDA批准的I-Portal®神经观念测试中心构建两个改造套件 （NOTC）和一个低成本的下一代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：迈阿密匹兹堡大学医学中心 医疗中心和梅奥诊所。第二个特定目的将集中于制定对齐方法 每个患者的头部测试所有运河和临床软件与硬件集成到硬件的测试协议 商业上可用的背心™软件。第三个特定目标将集中在临床测试上。全部的 这项研究的人口将入学：总研究队列的186名受试者的120例对照和66例患者。 66 患者将包括：30例手术确认的单侧验证损失，15例缺乏冰水热量 来自前庭神经毒素，21个具有诊断前庭偏头痛，以评估敏感性和特异性 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。重点 当前的实验将是对一般舒适度的评估和垂直的潜力 CRHIT刺激唤起运动疾病符号。测试和数据分析完成后，我们将提交 对FDA进行510K间隙的测试结果（特定目标＃4）。 FDA批准将使我们能够在商业上 将垂直CRHIT测试出售给前庭和咨询诊所。具体目标＃5是最终报告。