EEG Patch

脑电图贴片

• 批准号: 9254379
• 负责人: Mark J. Lehmkuhle
• 金额: $ 23.06万
• 依托单位: EPITEL, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9254379
• 关键词: Address; Adoption; Adverse effects; Applications Grants; Bathing; Benchmarking; Businesses; Clinical; Colorado; Computerized Medical Record; Data; Detection; Development; Device Designs; Devices; Diagnosis; Electrodes; Electroencephalography; Electronics; Environment; Epilepsy; Equilibrium; Event; Family; Feasibility Studies; Freedom; Goals; Gold; Home environment; Hospitals; Individual; Legal patent; Letters; Life; Lithium; Location; Medical; Methods; Modeling; Monitor; Morphologic artifacts; Movement; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Phase; Physicians; Plague; Process; Recording of previous events; Records; Reporting; Research; Rodent Model; Scalp structure; Seizures; Services; Sleep; Sports; Subclinical Seizures; System; Technology; Testing; Therapeutic; Time; Universities; Validation; Wireless Technology; arm; base; biomaterial compatibility; clinical Diagnosis; commercialization; density; design; diaries; head-to-head comparison; high standard; improved; monitoring device; personalized medicine; prototype; standard of care; tool; treatment strategy

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 as spike-wave discharges and seizures. Having access to a more complete record of a person’s seizures may improve the treatment strategy to balance the side-effects of anti-seizure medication with seizure control. Due to a lack of long-term EEG data, clinicians are 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 Epitel’s EEG PatchTM | Long- clinicians with a long-term quantitative report of a person’s seizures term EEG recording of seizure suitable for at-home monitoring in their everyday environment that is occurrence for everyday use. not diary-based. Epitel will address this need in a Phase I feasibility study of the EEG Patch in the EEG long-term monitoring unit to address a specific enabling clinical capability:  A well-placed, single-channel EEG Patch can be used to count seizures just as accurately as the "gold- standard" wired EEG Epitel has developed its functional prototype EEG Patch, 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 (CR2330, 265 mAh). The unique robust design will provide users with complete mobility in daily activities The EEG Patch is unobtrusive and placed such as bathing, sports, and sleep during EEG monitoring, critical on the scalp by an epileptologist where for patient adoption. After a week of recording, the EEG Patch is seizures are known to manifest. Electrode returned to Epitel where a personalized report of EEG activity will spacing follows standard high-density be provided to both the user and the user’s epileptologist. 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 gateway to commercialization of the EEG Patch will be showing that a 1-channel, 2-electrode device can record location-specific seizure data as well as the gold standard wired EEG for up to 7 days. The long-term goal is for the EEG Patch to become the ‘at-home’ seizure reporting (counting) standard. 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.

摘要 EEG PatchTM是一种单通道、（2电极）可穿戴、贴片式 专为癫痫患者的长期EEG记录而设计的设备 在日常环境中使用。为了最大限度地治疗癫痫， 长期捕获EEG活动中重要的日常变化至关重要， 包括癫痫样事件的发生和持续时间，例如 棘波放电和癫痫有机会获得一个更完整的 记录一个人的癫痫发作可能会改善治疗策略， 抗癫痫药物的副作用与癫痫控制。由于缺乏 长期脑电图数据，临床医生被迫依赖癫痫日记， 自我报告缉获量的方法已被证明是不准确的， 经常误导，仅仅是因为这个人没有意识到他们已经有了 癫痫发作一个不显眼的，在家里，每周脑电图监测设备， 计数癫痫发作，可以彻底改变临床诊断和治疗 癫痫病患者的治疗方法EEG贴片设计用于 在传统的EEG已经确定癫痫发作开始的位置或一般化之后， 以便在癫痫发作时提供记录的最佳位置 （检获计数）。目前还没有设备可以提供Epitel的EEG PatchTM|长- 临床医生与一个人的癫痫发作长期定量报告术语脑电图记录癫痫发作 适合于在日常使用的日常环境中进行家庭监控。 不是基于日记的。 Epitel将在EEG长期监测装置中EEG贴片的第一阶段可行性研究中解决这一需求 解决特定的使能临床能力： 一个放置良好的单通道脑电图贴片可以用来计数癫痫发作，就像"黄金"一样准确， 标准"有线脑电图 Epitel已经开发出其功能原型EEG Patch， 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7天的EEG。脑电图 贴片功耗为1.14 mA（3.42 mW），由单个 锂原电池（CR2330，265 mAh）。独一无二的健壮 设计将为用户在日常活动中提供完全的移动性。EEG贴片不显眼， 如洗澡、运动和睡眠时的脑电图监测，关键的头皮上的癫痫病学家， 供病人领养经过一周的记录，脑电图补丁是癫痫发作是众所周知的表现。电极 返回Epitel，其中EEG活动的个性化报告将间隔遵循标准高密度 提供给用户和用户的癫痫病医生。有线脑电图 Epitel的单通道EEG Patch在癫痫长期监测单元中的癫痫发作记录 科罗拉多大学。迹线是一名患者的EEG，该患者入院接受视频EEG监测作为标准治疗。 将EEG贴片放置在有线电极之间，并通过全导联审查验证癫痫发作。 EEG贴片商业化的途径将表明，单通道、双电极设备可以 记录特定位置的癫痫发作数据以及长达7天的黄金标准有线EEG。远景目标 EEG Patch成为“在家”癫痫发作报告（计数）标准。脑电图的简单性 贴片可以更容易地获得更完整的定量EEG记录，以确定患者的病史。 比自我报告更准确。EEG Patch可以改善患者与医生的互动， 可以为癫痫的个性化治疗带来深刻的改变。