Intelligent Adaptive Wireless Reconfigurable EEG

说明(申请人提供)该提案的总体目标是利用创新的无线脑电系统改善动态和长期脑电监测。这项建议的具体目的是开发一种具有实时自适应和重新配置能力的移动无线脑电监测系统，使更多的临床数据能够在相同的带宽内以小型便携包进行传输。拟议的设备将使其数据采集硬件适应潜在的临床事件，从而使其能够将其高传输率集中在临床相关事件的时段。我们强大的癫痫监测算法将检测到这些事件，该算法将直接控制灵活和创新的硬件。其结果是在一个小包装中增强了无线脑电，低功率，数据质量可与更笨重的临床栓系系统相媲美。由于FDA新的遥测指南限制了医疗设备中频率和带宽的可用性，因此优化带宽的能力是及时的。优化输出的另一个好处是，可以创建更有意义的数据，而不需要过大的数据文件，这将加快分析和审查的速度。最后，建议的设备将能够动态地实时重新配置自己，以补偿严重的数据损坏事件，例如当一个或几个电极松动或分离时。总而言之，两个主要创新是：1-实时自适应能力，调整采集和传输的脑电数据的数量和质量，以更好地反映潜在的临床事件(如癫痫)；2-通过脑电采集系统的实时自动重新配置，实现更实用和更准确的动态监测。 在第一阶段，我们设计、制造并测试了一个原型系统。台式和临床测试表明，该系统确实可以根据脑电形态中的伪影或变化来修改其输出。在第二阶段，我们将完成开发，包括符合FDA新指南的无线电设计，并在长期癫痫患者身上进行测试。

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.