Nystagmus-Based Repositioning System - Vestibular Disor.

描述（由申请人提供）： Vesticon正在开发一种基于眼球震颤的重新定位（NBR）系统（在第一阶段称为头戴式位置管理系统），用于诊断和治疗眩晕的位置表现，并在医疗机构中应用。NBR系统将提供眼球震颤的高级、快速分析以及图形和文本指导，以便在检查床上手动执行重新定位操作（RM）。头晕和平衡障碍是常见的问题，有620万40至69岁的美国人长期受到影响，大多数70岁以上的人报告平衡问题，其中平衡相关的福尔斯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（BPPV）。目前的诊断和治疗方案限制了最佳护理和预防不良后果。此外，现有技术是在BPPV被充分理解之前开发的，因此诊断实用性有限，并且不用于治疗。 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型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南。第一阶段的目标已经达到或超过：我们通过软件和硬件组件将3-D VNG软件与惯性传感器集成在一起，并开发了基本的机动协议和具有实时条件交互式3-D动画的一级制导。然后，我们在一个小型受试者队列的人体可行性研究中证明了原型的临床价值。在第二阶段，我们将：a）从1000多个数据库、外部专家评审和测试站点反馈中开发先进的诊断和治疗方案; B）开发额外的软件和硬件以实施和集成方案，包括VNG算法改进、优化和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的测试单元; d）在具有大受试者群体的人类研究中证明改进的临床应用。

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.