High Performance Seizure Monitoring and Alert System

 描述(由申请人提供)：患者经常因癫痫或急性神经损伤(如创伤、中风、感染和一些毒性和代谢障碍)导致的失控癫痫而住院治疗。然而，由于癫痫发作是间歇性的和不可预测的，因此患者的癫痫发作没有被发现的情况并不少见，这使得住院治疗癫痫的治疗变得复杂。这可能会导致不必要的住院时间延长，或者更糟糕的是，延误治疗和不可逆转的脑损伤。因此，迫切需要开发一套准确的床边癫痫监测与报警系统。这个SBIR项目的总体目标仍然是开发CereScope并将其商业化，CereScope是一种一体化的高质量全头皮(10-20系统)脑电采集设备，具有实时信号显示、实时电极阻抗监测以及高性能癫痫监测和警报(SMA)的能力。预期的临床环境包括但不限于动态脑电监测、癫痫监测病房(EMU)、重症监护病房(ICU)、急诊科(ED)以及神经科和神经外科患者的普通护理病房。Optima神经科学的研究人员已经开发了几种自动化算法，通过分析头皮EEG信号的时空模式来准确检测癫痫发作(针对不同的患者群体)。用于成年EMU患者的算法被纳入我们的IdentEvent癫痫检测软件，该软件于2009年10月16日获得FDA批准。在这个SBIR项目的第一阶段和第二阶段，我们完成了CereScope的(1)硬件设计和软件实施，(2)电气安全(UL)测试，(3)对正常志愿者的信号质量评估，(4)与SMA模块的完全集成，以及(5)对EMU患者的初步临床研究。在这些成就的基础上，在我们研究团队的大力支持下，我们现在提出在此IIB阶段应用程序中扩展CereScope诊断实用程序的途径。已有充分的证据表明，尽管存在一些潜在的相似之处，但在这些患者群体中，发作期和背景脑电模式都存在显著差异。因此，为了确保CereScope的临床实用性，在这一IIB阶段的应用中，我们建议进行三项临床研究，每项研究针对不同的患者群体。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信号的情况，同时分析可能的癫痫事件的发送警报。研究还将生成性能统计数据(敏感度和 误检率)对癫痫的实时检测。该IIB阶段有以下具体目标：(1)针对成人动车组患者的CereScope(Tm)的完整性能验证；(2)针对成人非卧床cEEG患者的CereScope(Tm)的完整性能验证；以及(3)针对成人ICU患者的CereScope(Tm)的完整性能验证。CereScope(Tm)的成功商业化将通过允许检测间歇性和以前被误诊的事件来改善住院患者对癫痫发作的管理。

 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.