Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth

测试用于脑电图远程医疗的新型干电极耳机

• 批准号: 10595484
• 负责人: Jonathan Jacob Halford
• 金额: --
• 依托单位: RALPH H JOHNSON VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10595484
• 关键词: Address; Ambulatory Care Facilities; Amplifiers; Appointment; Blinded; Board Certification; Caring; Clinic; Clinical; Clinical Trials; Communities; Computer software; Cost Savings; Costs and Benefits; Data; Devices; Diagnostic Procedure; Discipline of Nursing; Dryness; Electrodes; Electroencephalography; Epilepsy; Equipment; Equipment and Supplies; Evaluation; Event; FDA approved; Head; Health Services Accessibility; Healthcare Systems; Hour; Improve Access; Internet; Interview; Location; Measures; Medical center; Methodology; Methods; Minor; Mission; Modality; Morphologic artifacts; Neurologic; Neurologist; Nurses; Outpatients; Patient Care; Patients; Pattern; Performance; Preparation; Probability; Procedures; Randomized, Controlled Trials; Recording of previous events; Research; Research Personnel; Research Priority; Research Proposals; Research Subjects; Rural Community; Rural Health; Schedule; Seizures; Signal Transduction; Site; Skin; System; Telemedicine; Testing; Time; Training; Travel; Veterans; Visit; Wages; Wait Time; cost; epileptiform; improved; innovation; novel; outreach program; procedure cost; prospective; recruit; remote location; rural area; rural residence; telehealth; transmission process

Background: Many Veterans live far away from a VAMC with substantial electroencephalography (EEG) expertise. Travel is difficult for epilepsy patients since they often cannot drive. We propose to study a novel dry electrode system (DES) which does not require EEG technologists to operate and can be operated by a nurse assistant. This DES integrates the electrodes and EEG amplifier into a compact headset which is easily placed on the head (without skin preparation) and could be used in an epilepsy telemedicine outreach program along with clinical interviews. We have performed three preliminary studies with DES headsets. In our first two studies in 33 Veterans performed at a VAMC, we found that the DES was quick to apply, taking only 5-6 minutes to put on by a research subject with the assistance of a neurologist. Subjects preferred the DES headset over the standard EEG system (SES). In our third study a nurse performed 30 DES recordings in a VA community based outpatient clinic (CBOC). Rating of the EEG recordings on a five point scale by three board certified clinical EEG experts (after automated EEG artifact reduction was applied to the recordings) showed that all 30 recordings were of acceptable quality (rated 3 out of 5 or higher with some artifact present) and 18 of 30 recordings were of good quality (rate 4 or above with only minor artifacts present). Significant Impact: This study will improve access of Veterans with epilepsy living in rural areas to the most important diagnostic procedure for the care of patients with epilepsy: the routine EEG. Being able to perform routine EEG in CBOCs can decrease cost to the VA system since DES EEG systems are less expensive and because Veterans will not have to travel to VAMCs for EEG. This study will also test the DES system to make sure it can record epileptiform transients (ETs), the pattern in EEG which indicates that patients have epilepsy. Innovation: This study is innovative because it will use a new recording system for EEG that just got FDA approval. This new DES EEG recording system provides a method for recording EEG which is cheaper and much easier to perform than conventional EEG. This study is also innovative because it will test for the first time if a DES can reliably record ETs. (The FDA approval for the DES system was based on EEG signal quality only and not whether it could reliably detect ETs.) The study will also use a new FDA-approved method for automatically removing artifactual signals which can obscure DES EEG recordings. Specific Aims: The first aim of the project is to test the ability of the DES to record ETs versus the SES. The second aim is to collect data on appointment wait time, appointment cancellation rate, and procedure cost of DES versus SES to project the improvement in Veteran access and potential cost-benefit of DES EEG performed in CBOCs versus SES EEG performed in VAMCs. Methodology: This is a randomized controlled trial which will be performed at three sites: the Charleston VAMC, Durham VAMC, and Miami VAMC. For Specific Aim 1, 400 Veterans (200 with a history of an abnormal EEGs in which ETs were recorded and 200 prospective Veterans scheduled for an outpatient EEG) will be recruited to have a DES EEG procedure and a SES EEG procedure performed during a single study visit in a VAMC by an EEG technologist. Each EEG recording will be interpreted and rated for technical quality by three study investigators, who will also annotate the location of ETs in each EEG recording. The fraction of EEGs which demonstrate ETs and the technical quality ratings will be compared. For Specific Aim 2, data will be collected on 300 prospective Veterans scheduled for an outpatient routine EEG, including appointment cancellation rate, travel cost, and other patient factors. Costs for EEG equipment/supplies as well as technician effort/salary and nurse and nurse assistant effort/salary will also be collected. This will be used to project the potential improvement in patient access and potential cost savings of a nurse or nurse technician performing outpatient DES EEG in a CBOC versus an EEG technician performing outpatient SES EEG in a VAMC.

背景：许多退伍军人居住在远离VAMC的地方，并且有大量的脑电图（EEG） 专业知识癫痫患者很难旅行，因为他们通常不能开车。我们建议研究一种新的干 电极系统（DES），不需要EEG技术人员操作，可由护士操作 助手该DES将电极和EEG放大器集成到一个紧凑的耳机中，易于放置 在头部（没有皮肤准备），并可用于癫痫远程医疗外展计划沿着 临床面试。我们已经用DES头戴式耳机进行了三项初步研究。在我们的前两个 在VAMC进行的33名退伍军人的研究中，我们发现DES应用迅速，仅需5-6 在神经科医生的帮助下，研究对象需要几分钟的时间。受试者首选DES 标准EEG系统（SES）。在我们的第三项研究中，护士在VA中进行了30次DES记录 社区门诊（Community Based Outpatient Clinic，CBOC）。由三个委员会在五分量表上对EEG记录进行评级 经认证的临床EEG专家（在对记录应用自动EEG伪影减少后）显示， 所有30个记录都具有可接受的质量（5分之3或更高，存在一些伪影）， 30个记录的质量良好（4级或以上，仅存在轻微伪影）。 重大影响：这项研究将改善生活在农村地区的癫痫退伍军人获得最 重要的诊断程序的照顾癫痫患者：常规脑电图。能够执行 CBOC中的常规EEG可以降低VA系统的成本，因为DES EEG系统更便宜， 因为退伍军人将不必前往VAMC进行EEG。本研究也将测试DES系统， 当然，它可以记录癫痫样瞬变（EEG）的模式，这表明病人患有癫痫。 创新：这项研究是创新的，因为它将使用一种新的记录系统，脑电图，刚刚获得FDA 批准这种新的DES EEG记录系统提供了一种用于记录EEG的方法， 比传统脑电图更容易执行。这项研究也是创新的，因为它将测试第一个 时间，如果DES可以可靠地记录时间。(The FDA批准DES系统是基于EEG信号 仅限于质量，而不是它是否能够可靠地检测到缺陷。该研究还将使用FDA批准的新方法 用于自动去除可能掩盖DES EEG记录的伪信号。 具体目标：该项目的第一个目标是测试DES与SES相比记录时间的能力。的 第二个目标是收集预约等待时间，预约取消率和程序成本的数据， DES与SES，以预测DES EEG在退伍军人访问和潜在成本效益方面的改善 在CBOC中进行的EEG与在VAMC中进行的SES EEG。 方法：这是一项随机对照试验，将在三个地点进行：查尔斯顿 VAMC，达勒姆VAMC，和迈阿密VAMC。1400名退伍军人（200名有异常病史的退伍军人） 记录EEG，并安排200名预期退伍军人进行门诊EEG） 招募了一名患者，在一次研究访视期间进行DES EEG程序和SES EEG程序， 由EEG技术专家进行VAMC。每个EEG记录将由三个人进行解释和技术质量评级 研究人员，他们也将在每个EEG记录中注释EEG的位置。脑电图分数 这表明，将比较技术质量等级和技术质量等级。对于具体目标2，数据将 收集了300名预定进行门诊常规EEG的潜在退伍军人，包括预约 取消率、旅行成本和其他患者因素。EEG设备/用品以及技术员费用 工作量/工资以及护士和护士助理工作量/工资也将收取。这将被用来预测 潜在的患者访问的改善和潜在的成本节省的护士或护士技术员执行 CBOC中的门诊DES EEG与VAMC中进行门诊SES EEG的EEG技术人员。