CPS: Synergy: Collaborative Research: Fault Tolerant Brain Implantable Cyber-Physical System

CPS：协同：协作研究：容错大脑可植入网络物理系统癫痫是最常见的神经疾病之一，影响世界人口的0.4%至1%。虽然大约三分之二的新诊断患者可以通过使用一种或多种抗癫痫药物(AED)来控制癫痫发作，但其余的患者即使在服用多种药物时也会出现癫痫发作。癫痫的慢性状态对患者的主要影响是生活质量降低、生产力丧失、并存和死亡风险增加。癫痫是一种间歇性脑疾病，在定位相关癫痫中，癫痫最常见的形式是一个或几个离散的大脑区域(癫痫灶或癫痫灶)，被认为是癫痫发作的始发部位。最近使用植入式电刺激癫痫控制装置的方法作为控制癫痫发作的一种治疗选择具有价值。这些装置直接或间接地瞄准癫痫发作的焦点，并试图控制其表达。在这个项目中，我们将基于新兴的网络物理系统(CPS)原理建立一个多通道脑植入设备。这种大脑植入型CPS设备将结合关键的设计特征，使设备可靠、可扩展、可组合、可认证和可互操作。该设备将在动物或患者的一生中运行，并持续记录大脑活动，并在检测到与癫痫相关的活动时刺激大脑，以中止即将到来的癫痫发作。癫痫等发作性大脑疾病对患者的生产力和生活质量有相当大的影响，当癫痫发作无法通过药物控制时，可能会危及生命。该项目的目标是基于新兴的CPS原理和实践创建第二代脑植入传感和刺激设备(BISSD)。BISSD的发展例证了几个明确的方面，这些方面提供了信息并说明了CPS的核心原则。首先，为了应对监管审批的重要挑战，提出了一个支持多物种测试的可组合、可扩展和可认证的框架。其次，BISSD必须与患者完全整合，并在大脑状态的每一个瞬间充分认识，包括大脑生理正常和异常表达的动态变化和治疗干预。因此，该项目寻求网络解决方案与物理系统的紧密结合，网络解决方案必须使用植入的、可适应的、分布式的和联网的电极来监控自己并监控和刺激大脑，在这种情况下，物理系统是间歇性故障的人脑。第三，BISSD必须在很长一段时间内发挥作用，直到患者的生命，因为放置和取回BISSD的每一次手术都伴随着风险。这一要求需要一个可靠的解决方案，这个项目寻求通过了解大脑的异物反应和独特的分层容错设计来可靠地实现这一解决方案。第四，采用先进的显著方法采集、压缩和分析传感器信号，实现对癫痫发作的实时监测和控制。该项目应该产生一个强大的、可扩展的CPS框架，用于具有实时处理的健壮容错植入式医疗设备，该框架可以随着传感器、传感模式、时间序列分析、实时计算、控制、材料、功率和潜在生物知识的进步而增长。美国在控制难治性癫痫发作方面具有竞争优势。在现代，癫痫外科手术于20世纪70年代在美国发展起来，并从这里传播到世界其他地区。同样，美国在BISSD方面享有竞争优势，这一努力的成功将使美国能够建立和保持这一优势。除了癫痫，这方面的进展有望有益于其他神经和精神性脑部疾病的治疗。

CPS: Synergy: Collaborative Research: Fault Tolerant Brain Implantable Cyber-Physical SystemEpilepsy is one of the most common neurological disorders, affecting between 0.4% and 1% of the world's population. While seizures can be controlled in approximately two thirds of newly diagnosed patients through the use of one or more antiepileptic drugs (AEDs), the remainder experience seizures even on multiple medications. The primary impacts of the chronic condition of epilepsy on a patient are a lower quality of life, loss of productivity, comorbidities, and increased risk of death. Epilepsy is an intermittent brain disorder, and in localization-related epilepsy, which is the most common form of epilepsy, one or a few discrete brain areas (the seizure focus or seizure foci) are believed to be responsible for seizure initiation. More recent approaches with implantable electrical stimulation seizure control devices hold value as a therapeutic option for the control of seizures. These devices, directly or indirectly, target the seizure focus and seek to control its expression. In this project we will build a multichannel brain implantable device based on emerging cyber physical system (CPS) principles. This brain implantable CPS device will incorporate key design features to make the device dependable, scalable, composable, certifiable, and interoperable. The device will operate over the life of an animal, or a patient, and continuously record brain activity and stimulate the brain when seizure related activity is detected to abort an impending seizure.Episodic brain disorders such as epilepsy have a considerable impact on a patient's productivity and quality of life and may be life-threatening when seizures cannot be controlled with medications. The goal of this project is to create a second generation brain-implantable sensing and stimulating device (BISSD) based on emerging CPS principles and practice. The development of a BISSD as a exemplifies several defining aspects that inform and illustrate core CPS principles. First, to meet the important challenge of regulatory approval a composable, scalable and certifiable framework that supports testing in multiple species is proposed. Second, a BISSD must be wholly integrated with the patient and fully cognizant at every instant of brain state, including dynamic changes in both the normal and abnormal expression of brain physiology and therapeutic intervention. Thus, this project seeks a tight conjunction of the cyber solution that must monitor itself and monitor and stimulate the brain using implanted, adaptable, distributed, and networked electrodes, and the physical system which in this case is the intermittently failing human brain. Third, a BISSD must function for an extensive period of time, up to the life of the patient, because each surgery to place and retrieve a BISSD carries an attendant risk. This requirement necessitates a dependable solution, which this project seeks to reliably achieve through both an understanding of the brain's foreign body response and a unique hierarchical fault-tolerant design. Fourth, an advanced salient approaches to acquire, compress, and analyze sensor signals to achieve real-time monitoring and control of seizures is employed. This project should yield a powerful, scalable CPS framework for robust fault-tolerant implantable medical devices with real-time processing that can grow with advances in sensors, sensing modalities, time-series analysis, real-time computation, control, materials, power and knowledge of underlying biology. The USA has a competitive advantage in the control of seizures in medically refractory epilepsy. In the modern era, epilepsy surgery evolved in the USA in the 1970s and spread from here to other parts of the world. Similarly, the USA enjoys a competitive advantage in BISSDs, and success in this effort will enable the USA to build on and maintain this advantage. In addition to epilepsy, advances made here can be expected to benefit the treatment of other neurological and psychiatric brain disorders.