Nystagmus-Based Repositioning System - Vestibular Disor.

描述(由申请人提供)： Vesticon正在开发一种基于眼震的重新定位(NBR)系统(在第一阶段称为头盔位置管理系统)，用于诊断和治疗眩晕的位置表现，适用于医疗设施。NBR系统将提供先进、快速的眼震分析，以及在检查台上手动执行重新定位动作(RMS)的图形和文本指导。头晕和平衡障碍是常见的问题，有620万美国人在40岁到69岁之间长期受到影响，70岁以上的人中大多数报告有平衡问题，与平衡有关的跌倒占老年人意外死亡的一半以上。最常见的前庭疾病是位置性眩晕，简称BPPV。目前的诊断和治疗方案限制了最佳护理和不良后果的预防。此外，现有的技术是在BPPV被很好地理解之前开发的，因此，诊断用途有限，并且不是为治疗而设计的。NBR系统将监测空间方向和头部/躯干运动，结合视频眼球运动和新颖的3-D眼球震颤分析，以直观的3-D动画显示数据，并为诊断和治疗操作提供指导。达到或超过了第一阶段的目标：我们通过软硬件组件将3-D VNG软件与惯性传感器集成在一起，开发了基本的机动协议和带有实时条件的交互式3-D动画的一级制导。然后，我们在一项小型受试者队列的人体可行性研究中展示了该原型的临床价值。在第二阶段，我们将：a)从1000多个数据库、外部专家评审和Beta现场反馈开发先进的诊断和治疗方案；b)开发额外的软件和硬件来实施和集成方案，包括VNG算法改进、优化和具有优于现有前庭技术的PC硬件解决方案；c)开发四个具有无线传输功能的Beta单元；d)在具有大量受试者的人体研究中展示改进的临床应用。

DESCRIPTION (provided by applicant): Vesticon is developing a Nystagmus-Based Repositioning (NBR) System (known in Phase I as Headmounted Positional Management System) for diagnosis and treatment of positional manifestations of vertigo for application at medical facilities. The NBR System will provide advanced, rapid analysis of nystagmus and graphic and textual guidance for carrying out repositioning maneuvers (RMs) manually on an exam table. Dizziness and balance disorders are common problems, with 6.2 million Americans chronically affected between ages 40 and 69, and a majority of those over age 70 reporting balance problems, where balance related falls account for more than half of accidental deaths in the elderly. The most common vestibular disorder is positional vertigo, or BPPV. Current diagnostic and treatment protocols limit optimal care and prevention of untoward consequences. Additionally, existing technology was developed before BPPV was well understood and, therefore, has limited diagnostic utility and is not designed for treatment. The NBR System will monitor spatial orientation and head/ torso motion, coupled with videographic eye movements and novel 3-D nystagmus analysis, to display data in intuitive 3-D animation, and provide guidelines for diagnostic and treatment maneuvers. Phase I goals were met or exceeded: we integrated 3-D VNG software with inertia sensors via software and hardware components and developed basic maneuver protocols and first-level guidance with interactive 3-D animation of real-time conditions. We then demonstrated clinical value of the prototype in a human feasibility study with a small subject cohort. For Phase II, we will: a) develop advanced diagnosis and treatment protocols from 1000+ database, outside expert review and beta site feedback; b) develop additional software and hardware to implement and integrate protocols, including VNG algorithm refinement, optimization and a PC hardware solution with advantages over existing vestibular technology; c) develop four beta units with wireless transmission; d) demonstrate improved clinical applications in a human study with a large subject population.