High Performance Seizure Monitoring and Alert System

 描述（由申请人提供）：患者经常住院治疗癫痫或急性神经损伤（如创伤、中风、感染和多种毒性和代谢性疾病）引起的不受控制的癫痫发作。然而，癫痫发作的住院管理由于其间歇性和不可预测性发生而变得复杂，因此患者的癫痫发作未被识别的情况并不罕见。这可能导致不必要的住院时间延长，或更糟的是，治疗延迟和不可逆的脑损伤。因此，非常需要开发一种精确的床旁癫痫监测和警报（SMA）系统。 该SBIR项目的总体目标仍然是CereScope的开发和商业化，CereScope是一种一体化高质量全头皮（10-20系统）EEG采集设备，具有实时信号显示、实时电极阻抗监测以及高性能癫痫发作监测和警报（SMA）的能力。预期的临床环境包括但不限于，动态EEG监测、癫痫监测单元（EMU）、重症监护室（ICU）、急诊科（ED）以及神经科和神经外科患者的普通护理单元。Optima Neuroscience的研究人员开发了几种自动算法，通过分析头皮EEG信号的时空模式来准确检测癫痫发作（针对不同的患者人群）。成人EMU患者的算法被纳入我们的IdentEvent癫痫发作检测软件，该软件于2009年10月16日获得FDA批准。在SBIR项目的第一阶段和第二阶段，我们完成了CereScope的（1）硬件设计和软件实现，（2）电气安全（UL）测试，（3）正常志愿者受试者的信号质量评估，（4）与SMA模块的完全集成，以及（5）EMU患者的试点临床研究。在这些成就的基础上，在我们研究团队的大力支持下，我们现在在IIB期申请中提出了一种扩展CereScope诊断实用性的途径。 它已经被充分记录，尽管有一些潜在的相似之处，在这些患者人群中发作和背景EEG模式存在显着差异。因此，为了确保CereScope的临床效用，在本IIB期申请中，我们建议在不同的患者人群中进行三项临床研究。每项临床研究将在四个主要医疗中心进行。这些研究将评估CereScope记录视频和EEG信号的能力，同时分析可能的癫痫发作事件的发送警报。这些研究还将产生业绩统计数据（敏感性和 误检率）对实时癫痫发作检测的影响。本IIB期研究的具体目标如下：（1）完成CereScope（tm）用于成人EMU患者的性能确认，（2）完成CereScope（tm）用于成人非卧床cEEG患者的性能确认，以及（3）完成CereScope（tm）用于成人ICU患者的性能确认。 CereScope（TM）的成功商业化将通过检测间歇性和先前误诊的事件来改善癫痫发作的住院治疗。

 DESCRIPTION (provided by applicant): Patients are frequently hospitalized for management of uncontrolled seizures due to epilepsy or acute neurological insults such as trauma, stroke, infections, and a number of toxic and metabolic disorders. However, inpatient management of seizures is complicated by the fact that they occur intermittently and unpredictably, and thus it i not infrequent that patients' seizures go unrecognized. This can result in unnecessarily prolonged hospital stays, or worse, delay of treatment and irreversible brain injury. Therefore, there is a great need to develop an accurate bed-side seizure monitroing and alert (SMA) system. The overall goal of this SBIR project remains to be the development and commercialization of the CereScope, an all-in-one high-quality full-scalp (10-20 system) EEG acquisition device with capability of real-time signal display, real-time electrode impedance monitoring, as well as high-performance seizure monitoring and alert (SMA) in nearly real-time. Intended clinical settings include but are not limited to, ambulatory EEG monitoring, epilepsy monitoring units (EMUs), intensive care units (ICUs), emergency departments (EDs), and general care units for neurology and neurosurgical patients. Researchers at Optima Neuroscience have developed several automated algorithms to accurately detect seizures (for different patient populations) by analyzing the spatiotemporal patterns of scalp EEG signals. The algorithm for adult EMU patients was incorporated in our IdentEvent seizure detection software, which received FDA approval on October 16, 2009. During the Phase I and Phase II of this SBIR project, we completed CereScope's (1) hardware design and software implementation, (2) electric safety (UL) test, (3) signal quality assessment on normal volunteer subjects, (4) fully integration with the SMA module, and (5) pilot clinical study on EMU patients. Building upon these achievements and with the strong support of our research teams, we now propose in this Phase IIB application a pathway to expand the diagnostic utility of the CereScope. It has been well-documented that, despite of some underlying similarities, there exist significant differences in both ictal and background EEG patterns among these patient populations. Therefore, to ensure CereScope's clinical utility, in this Phase IIB application, we propose to conduct three clinical studies, each in a different patient population. Each clinical study will be conducted at four major medical centers. These studies will evaluate how well the CereScope records video and EEG signals while simultaneously analyzing the sending alerts for possible seizure events. The studies will also generate performance statistics (sensitivity and false detection rate) on real-time seizure detection. This Phase IIB has the following specific aims: (1) complete performance validation of CereScope(tm) for adult EMU patients, (2) complete performance validation of CereScope(tm) for adult ambulatory cEEG patients, and (3) complete performance validation of CereScope(tm) for adult ICU patients. Successful commercialization of CereScope(tm) will improve inpatient management of seizures by allowing for detection of intermittent and previously misdiagnosed events.