Intelligent Adaptive Wireless Reconfigurable EEG

描述（由申请人提供）该提案的总体目标是使用创新的无线EEG系统改善动态和长期EEG监测。本提案的具体目的是开发一种具有实时自适应和重新配置功能的动态无线EEG监测系统，这将允许在相同的带宽和小型便携式包装中传输更多的临床数据。申报器械将使其数据采集硬件适应基础临床事件，从而使其高传输速率集中于临床相关事件的周期。这些事件将被我们强大的癫痫监测算法检测到，该算法将直接控制灵活和创新的硬件。其结果是增强的无线脑电图在一个小的包装，低功耗和数据质量相媲美的笨重的临床系留系统。由于新的FDA遥测指南限制了医疗设备中频率和带宽的可用性，因此能够及时优化带宽。优化输出的另一个优点是，可以在没有过大数据文件的情况下创建更有意义的数据，这将加快分析和审查。最后，所提出的设备将能够在真实的时间内动态地重新配置自身，以补偿严重的数据破坏事件，例如当一个或多个电极变得松动或分离时。总之，两个主要创新是：1-用于调整所采集和传输的EEG数据的数量和质量以更好地反映潜在临床事件（诸如癫痫发作）的实时自适应能力，2-通过EEG采集系统的实时自动重新配置的更实用和准确的动态监测。 在第一阶段，我们设计，制造和测试了一个原型系统。实验室和临床测试表明，该系统确实可以修改其输出，以响应伪影或EEG形态的变化。在第二阶段，我们将完成开发，包括符合新FDA指南的无线电设计，并对长期癫痫患者进行测试。

DESCRIPTION (provided by the applicant) The overall goal of the proposal is to improve ambulatory and long-term EEG monitoring using an innovative wireless EEG system. The specific aim of this proposal is to develop an ambulatory wireless EEG monitoring system with real-time adaptive and re-configuration capabilities, which will allow more clinical data to be transmitted in the same bandwidth and in a small portable package. The proposed device will adapt its data acquisition hardware to the underlying clinical event permitting it to focus its high transmission rates to periods of clinically relevant events. The events will be detected by our powerful seizure monitor algorithm which will have direct control over a flexible and innovative hardware. The result is enhanced wireless EEG in a small package, low power and with data quality comparable to bulkier clinical tethered system. The ability to optimize bandwidth is timely due to new FDA telemetry guidelines, which restricts the availability of frequencies and bandwidths in medical devices. Another advantage to optimizing output is that more meaningful data can be created without excessively large data files, which will speed analysis and review. Finally, the proposed device will be able to dynamically reconfigure itself in real time to compensate for serious data-corrupting events such as when one or several electrodes become loose or detached. In summary, the two major innovations are: 1- Real-time adaptive capability for adjusting the quantity and quality of the acquired and transmitted EEG data to better reflect the underlying clinical event (such as a seizure), 2- more practical and accurate ambulatory monitoring by the real-time automatic reconfiguration of the EEG acquisition system. In Phase I, we designed, fabricated and tested a prototype system. Bench top and clinical testing showed that the system can indeed modify its output in response to artifacts or changes in EEG morphology. In Phase II, we will complete development including a radio design that meets the new FDA guidelines, and test on long-term patients with epilepsy.