A new Instrument to Quantify Dyskinesia In Patients with Parkinson's Disease

描述（由申请人提供）：Koronis Biomedical Technologies Corp.（KBT）提议创建一种新的仪器来量化帕金森病患者的运动障碍，帕金森病目前影响着150万美国人，并且每年估计有60，000例新病例。最近，人们对量化运动障碍感兴趣，运动障碍是左旋多巴的一种副作用，用于减轻帕金森病症状，用于评价药理学和手术干预，并作为左旋多巴给药方案的输入。到目前为止，已经有许多有前途的研究表明，通过对不同的身体部位进行加速度或陀螺仪测量，可以开发出与用修改的异常不自主运动（AIM）或Goetz量表分级的运动障碍具有良好相关性的算法。拟议的仪器将消除需要拴病人与电线，一个缺点，目前的仪器，通过使用低功耗，可扩展的无线网络。手术工具将包括两种类型的器械。第一个设备是电池供电的无线三轴陀螺仪和加速度计模块，其体积小于一立方英寸。第二个设备是一个可穿戴的无线数据记录器（衬衫口袋大小），它将从模块中收集数据。这将允许在用于运动捕捉的任何其他流动系统中找不到的易用性。可扩展的无线网络将使不同身体部位的几个模块同时运行。在第一阶段，KBT将建造一个体积不超过一立方英寸的原型，这将证明开发能够同步测量和传输数据的模块的可行性。KBT将证明该系统的性能等于或优于过去使用离散有线传感器的研究的可行性。在第二阶段，KBT将完成仪器开发，实验检测算法，并在临床测试中验证仪器和算法。

DESCRIPTION (provided by applicant): Koronis Biomedical Technologies Corp. (KBT) proposes to create a new instrument to quantify dyskinesia in patients with Parkinson's disease, which currently affects 1.5 million Americans and is growing by an estimated 60,000 new cases each year. Recently there has been interest in quantifying dyskinesia, a side effect of the levodopa that is used to reduce Parkinsonian symptoms, for the evaluation of pharmacological and surgical interventions and as input to the levodopa dosing schedule. To date there has been a number of promising studies that have shown by making acceleration or gyroscopic measurement on various body segments that is it possible to develop algorithms that show good correlation to dyskinesias graded with either a modified abnormal involuntary movement (AIM) or the Goetz scale. The proposed instrumentation will eliminate the need to tether patients with wires, a shortcoming of current instruments, by using a low power, expandable, wireless network. The instrumentation will consist of two types of devices. The first device is a battery-powered, wireless, three axis gyroscope and accelerometer module whose volume is less than one cubic inch. The second device is a wearable wireless data recorder (shirt pocket size) that will collect the data from the modules. This will allow an ease of use not found in any other ambulatory system for motion capture. The expandable wireless network will enable simultaneous operation of several modules on different body segments. In Phase I, KBT will build a prototype, whose volume is not greater than one cubic inch, which will demonstrate the feasibility of developing modules that can synchronously measure and transmit their data. KBT will prove feasibility demonstrating the proposed system's performance is equal to or better than past research, which uses discrete wired sensors. In Phase II, KBT will complete the instrumentation development, experiment with detection algorithms, and validate the instrument and algorithms in clinical tests.