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

Abstract: Epilepsy 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.