FEASIBILITY OF A COMBINED SEIZURE DETECTOR-VNS SYSTEM

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 一些植入迷走神经刺激治疗系统(Cyberonics，Inc)的癫痫患者可以通过在癫痫的临床部分手动启动迷走神经刺激来影响癫痫的进展，而另一些患者则无法从按需刺激中受益，因为他们在癫痫发作期间启动刺激的时间太晚或根本无法启动。本研究的主要目标是：1)论证在快速、自动、基于脑电的检测临床癫痫发作或代用品(对于本原则证明性研究)之后，使用计算机系统自动按需启动迷走神经刺激患者的可行性；2)收集作为计算机化系统一部分的癫痫检测算法的敏感性和特异性的预期数据；以及3)收集关于脑电电极数量如何影响系统敏感性和特异性的数据。次要目标是1)收集有关脑电触发的及时刺激迷走神经对临床发作持续时间和强度的临床影响的先导数据，以及2)收集先导数据以比较患者和我们的计算机化系统在临床癫痫发作后按需启动迷走神经刺激的潜伏期。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Some epilepsy patients implanted with the Vagus Nerve Stimulation Therapy System (Cyberonics, Inc) can affect the progression of a seizure by manually initiating on-demand stimulation of the vagus nerve during the clinical portion of the seizure, while others do not benefit from on-demand stimulation because they initiate the stimulation too late or are incapable of initiating it at all during the seizure. The primary objectives of this study are to: 1) Demonstrate the feasibility of using a computer system to automatically initiate on-demand vagus nerve stimulation in patients implanted with the VNS system following rapid, automatic, EEG-based detection of the electrographic onset of clinical seizures, or surrogates (for this proof-of-principle study) such as subclinical seizures or epileptiform activity; 2) Gather prospective data on the sensitivity and specificity of the seizure detection algorithm that is part of the computerized system; and 3) Gather data on how the number of EEG electrodes affect the sensitivity and specificity of the system. Secondary objectives are to 1) Gather pilot data on the clinical effect of timely, EEG-triggered stimulation of the vagus nerve on the duration and intensity of clinical seizures and 2) Gather pilot data to compare the latency with which a patient and our computerized system initiate on-demand vagus nerve stimulation following the electrographic onset of clinical seizures.