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)提议创建一种新的工具来量化帕金森氏症患者的运动障碍，该疾病目前影响着150万美国人，估计每年新增6万例。最近，人们对量化运动障碍感兴趣，这是左旋多巴的一种副作用，用于减轻帕金森症状，用于评估药理和手术干预措施，并作为左旋多巴给药时间表的输入。到目前为止，已经有一些很有希望的研究表明，通过对身体不同部位进行加速度或陀螺仪测量，有可能开发出与运动障碍的良好相关性的算法，这些算法可以用修改的异常不自主运动(AIM)或Goetz分级来分级。拟议的器械将通过使用低功率、可扩展的无线网络，消除用电线拴住患者的需要，这是目前器械的一个缺点。仪器将由两种类型的设备组成。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，体积不到一立方英寸。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。这将使运动捕捉的易用性在任何其他移动系统中找不到。可扩展的无线网络将允许不同车身部分上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将证明可行性，证明所提出的系统的性能与过去使用离散有线传感器的研究相当或更好。在第二阶段，KBT将完成仪器开发，测试检测算法，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.