FEASIBILITY OF A COMBINED SEIZURE DETECTOR-VNS SYSTEM

结合癫痫检测器-VNS 系统的可行性

• 批准号: 7718938
• 负责人: STEVEN C. SCHACHTER
• 金额: $ 0.34万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718938
• 关键词: Affect; Algorithms; Clinical; Computer Retrieval of Information on Scientific Projects Database; Computer Systems; Data; Detection; Electrodes; Electroencephalography; Epilepsy; Funding; Grant; Implant; Institution; Numbers; Patients; Research; Research Personnel; Resources; Seizures; Sensitivity and Specificity; Source; Subclinical Seizures; System; United States National Institutes of Health; base; clinical effect; computerized; detector; prospective; vagus nerve stimulation

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 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发作的临床部分期间手动启动迷走神经的按需刺激来影响癫痫发作的进展，而其他患者则无法从按需刺激中获益，因为他们启动刺激太晚或在癫痫发作期间根本无法启动刺激。本研究的主要目的是：1）证明在植入VNS系统的患者中使用计算机系统自动启动按需迷走神经刺激的可行性，该系统可快速、自动、基于EEG检测临床癫痫发作或替代发作的电描记发作（对于本原理验证研究），如亚临床癫痫发作或癫痫样活动; 2）收集关于作为计算机化系统的一部分的癫痫发作检测算法的灵敏度和特异性的前瞻性数据;以及3）收集关于EEG电极的数量如何影响系统的灵敏度和特异性的数据。 次要目的是1）收集关于迷走神经的及时EEG触发刺激对临床癫痫发作的持续时间和强度的临床影响的试验数据，以及2）收集试验数据以比较患者和我们的计算机化系统在临床癫痫发作的电描记发作后启动按需迷走神经刺激的延迟。