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EEG Patch

脑电图贴片

基本信息

批准号：
9767292
负责人：
Mark J. Lehmkuhle
金额：
$ 58.93万
依托单位：
EPITEL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-30 至 2021-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9767292
关键词：
Adhesives Adoption Adult Applications Grants Archives Bathing Businesses Child Clinic Clinical Clinical Trials Colorado Computer software Computerized Medical Record Custom Data Development Device Designs Devices Diagnosis Docking Electrodes Electroencephalography Electronics Engineering Environment Epilepsy Equilibrium Event Feasibility Studies Feedback Freedom Goals Gold Home environment Individual Legal patent Lithium Location Medical Medical Device Methods Modeling Monitor Morphologic artifacts Movement Patient Self-Report Patients Persons Pharmaceutical Preparations Phase Physicians Plague Protocols documentation Recording of previous events Reporting Safety Scalp structure Seizures Services Signal Transduction Sleep Sterility Subclinical Seizures Technology Testing Therapeutic Time Universities Validation Visual Wireless Technology Work base biomaterial compatibility clinical Diagnosis density design diaries high standard improved meetings monitoring device off-patent personalized medicine side effect standard of care tool usability

项目摘要

ABSTRACT The EEG PatchTM is a single channel, (2 electrode) wearable, patch-like device designed for long-term, EEG recording in people with epilepsy to be used in their everyday environment. To maximize the treatment of epilepsy, it is critical to capture important day-to-day changes in EEG activity for long periods including the occurrence and duration of epileptiform events such The EEG Patch is unobtrusive and placed as spike-wave discharges and seizures. Having access to a more on the scalp by an epileptologist where complete record of a person’s seizures may improve the treatment seizures are known to manifest. Electrode strategy to balance the side-effects of anti-seizure medication with spacing follows standard high-density seizure control. Due to a lack of long-term EEG data, clinicians are wired EEG. forced to rely on seizure diaries, a method of self-reporting seizures that has been shown to be inaccurate and often misleading, simply because the person does not realize they have had a seizure. An unobtrusive, at-home, weekly EEG monitoring device capable of counting seizures, could revolutionize clinical diagnoses and therapeutic actions for people living with epilepsy. The EEG Patch is designed to be used after traditional EEG has determined where seizures begin or generalize so as to provide the optimal location(s) for recording when seizures occur (seizure counting). There is currently no device that can provide clinicians with a long-term quantitative report of a person’s EEG seizures suitable for at- home monitoring in their everyday environment that is not diary-based. The EEG Patch is a wireless 1 channel (2 electrode) differentially amplified transmitter and data logger, capable of recording EEG for 7 days. The EEG Patch draws 1.14 mA (3.42 mW) and is powered by a single lithium primary battery. The unique robust design provides users with complete mobility in daily activities such as bathing and sleep during EEG monitoring, critical for patient adoption. After a week of recording, the EEG Patch is returned to Epitel where a personalized report of EEG activity is archived in the user’s electronic medical records. In Phase I, Epitel demonstrated a critical enabling clinical capability in a feasibility study of the EEG Patch in the epilepsy monitoring unit:  A well-placed, single-channel EEG Patch can be used to count seizures just as accurately as the "gold- standard" wired EEG Seizure recording from Epitel’s single-channel EEG Patch in the epilepsy long-term monitoring unit at the University of Colorado. Traces are EEG from a patient admitted for video-EEG monitoring as standard-of-care. The EEG Patch was placed between wired electrodes and the seizure verified with full-montage review. The long-term goal is for the EEG Patch to become the ‘at-home’ seizure counting standard as the only device capable of recording convulsive (clinical) and non-convulsive (subclinical) seizures. In Phase II, Epitel will:  Develop a semi-automated EEG seizure extraction tool that reduces the time it takes for expert visual review of EEG from 7 days to <2 h using a custom GUI for seizure counting  Take the EEG Patch out of the clinic and in the user’s home for a final feasibility study.  Third party testing of biocompatibility, electrical safety, and medical package sterility  Gain feedback from a pre-submission meeting with FDA prior to clinical validation  Clinical EEG Patch validation in adults and children with epilepsy  Post-hoc validation of the seizure review software with EEG Patch single-channel EEG The simplicity of the EEG Patch makes it easier to obtain a more complete, quantitative EEG record that identifies a history of a patient’s seizures with more accuracy than self-reporting. The EEG Patch could improve patient- physician interaction that could make a profound change in the personalized treatment of epilepsy.

抽象的 EEG PatchTM 是单通道（2 个电极）可穿戴、专为长期脑电图记录而设计的贴片式设备患有癫痫症的患者可在日常环境中使用。到最大限度地治疗癫痫，关键是要抓住长期脑电图活动的重要日常变化包括癫痫样事件的发生和持续时间，例如脑电图贴片不显眼并放置如尖波放电和癫痫发作。癫痫病专家对头皮进行了更多的了解，其中完整记录一个人的癫痫发作可能会改善已知癫痫发作的治疗。电极平衡抗癫痫药物副作用的策略与遵循标准高密度的间隔癫痫发作控制。由于缺乏长期脑电图数据，临床医生采用有线脑电图。被迫依赖癫痫日记，一种自我报告的方法癫痫发作已被证明不准确且常常具有误导性，仅仅是因为该人没有意识到他们癫痫发作。一种不显眼的家用每周脑电图监测设备，能够计算癫痫发作次数，可以彻底改变癫痫患者的临床诊断和治疗行动。脑电图补丁是设计用于在传统脑电图确定癫痫发作开始或概括的位置后使用，以便提供记录癫痫发作时的最佳位置（癫痫发作计数）。目前还没有设备可以可以为临床医生提供适合以下情况的人脑电图癫痫发作的长期定量报告：日常环境中的家庭监控不是基于日记的。 EEG 贴片是一款无线 1 通道（2 电极）差分放大发射器和数据记录器，能够记录脑电图7天。 EEG 贴片消耗 1.14 mA (3.42 mW) 电流，由单个锂电池供电原电池。独特的坚固设计为用户在沐浴等日常活动中提供了完全的灵活性脑电图监测期间的睡眠，这对于患者采用至关重要。经过一周的记录，脑电图补丁是返回 Epitel，脑电图活动的个性化报告存档在用户的电子病历中。在第一阶段，Epitel 在脑电图贴片的可行性研究中展示了关键的临床能力。癫痫监测单位：  放置良好的单通道脑电图贴片可用于计数癫痫发作，就像“金- 标准”有线脑电图癫痫长期监测装置中 Epitel 单通道脑电图贴片的癫痫发作记录科罗拉多大学。痕迹是来自入院进行视频脑电图监测作为护理标准的患者的脑电图。将脑电图贴片放置在有线电极之间，并通过全蒙太奇检查验证癫痫发作。长期目标是让脑电图贴片成为“家庭”癫痫发作计数标准的唯一设备能够记录惊厥（临床）和非惊厥（亚临床）癫痫发作。在第二阶段，Epitel 将：  开发半自动脑电图癫痫发作提取工具，减少专家目视所需的时间使用自定义 GUI 进行癫痫发作计数从 7 天到 <2 小时的脑电图检查  将脑电图贴片带出诊所并放在用户家中进行最终可行性研究。生物相容性、电气安全和医疗包装无菌的第三方测试  在临床验证之前通过与 FDA 举行的提交前会议获得反馈成人和儿童癫痫患者的临床脑电图贴片验证  使用 EEG Patch 单通道 EEG 对癫痫发作审查软件进行事后验证脑电图贴片的简单性使得更容易获得更完整、定量的脑电图记录来识别患者的癫痫病史比自我报告更准确。脑电图贴片可以改善患者医生的互动可能会对癫痫的个性化治疗产生深远的变化。