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距离有大量脑电(EEG)的VAMC很远的地方 专业知识。对于癫痫患者来说，旅行是困难的，因为他们经常不能开车。我们建议研究一种新的干式 电极系统(DES)，不需要脑电技术人员操作，可由护士操作 助理。这种DES将电极和脑电放大器集成到一个易于放置的紧凑型耳机中 在头部(不需要皮肤准备)，并可用于癫痫远程医疗推广计划 与临床面谈。我们已经对DES耳机进行了三项初步研究。在我们的前两个节目中 在VAMC对33名退伍军人进行的研究中，我们发现DES应用迅速，只需5-6 在神经科医生的帮助下，研究对象需要几分钟的时间。受试者更喜欢DES 将耳机置于标准脑电系统(SES)之上。在我们的第三项研究中，一名护士在VA中进行了30次DES录音 社区门诊(CBOC)。三块板对脑电记录五点制的评定 经过认证的临床脑电专家(在将自动脑电伪影减少应用于记录后)显示 所有30段录音的质量都是可接受的(满分5分中有3分或更高，有一些人工制品)和18段 30段录音的质量很好(4级或以上，只有少量人工制品)。 重大影响：这项研究将最大限度地改善居住在农村地区的退伍军人癫痫患者的机会 癫痫患者护理的重要诊断程序：常规脑电检查。能够执行任务 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，而且 因为退伍军人将不必前往VAMC进行脑电检查。本研究还将对DES系统进行测试，使 当然，它可以记录癫痫样瞬变(ETS)，这是脑电中表明患者患有癫痫的模式。 创新：这项研究具有创新性，因为它将使用一种新的脑电记录系统，该系统刚刚获得FDA批准 批准。这种新的DES脑电记录系统提供了一种更便宜、更方便的脑电记录方法 比传统的脑电检查更容易进行。这项研究也是创新的，因为它将第一次测试 DES能否可靠地记录ETS的时间。(FDA对DES系统的批准是基于脑电信号 仅限质量，而不是它是否能可靠地检测到ETS。)这项研究还将使用FDA批准的一种新方法 用于自动去除可能遮挡DES脑电记录的伪像信号。 具体目标：该项目的第一个目标是测试DES记录ETS和SES的能力。这个 第二个目标是收集关于预约等待时间、预约取消率和程序成本的数据 DES与SES的对比，以预测DES EEG在退伍军人准入和潜在成本效益方面的改善 在CBOC中进行脑电检查，而在VAMC中进行SES EEG检查。 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、达勒姆和迈阿密VAMC。针对特定目标，1400名退伍军人(200名有异常病史的退伍军人 记录了ETS的EEG和计划进行门诊EEG的200名准退伍军人) 在一次研究访问期间被招募进行DES EEG程序和SES EEG程序 由脑电技术专家进行的VAMC。每个脑电记录将被解释，并根据三个人的技术质量进行评级 研究调查人员，他们还将在每个脑电记录中注释ETS的位置。脑电的比例 其中展示的ETS和技术质量评级将进行比较。对于特定目标2，数据将是 收集了300名计划进行门诊常规脑电检查的准退伍军人，包括预约 取消率、旅行费用和其他患者因素。脑电设备/用品以及技术人员的费用 努力/工资和护士和护士助理的努力/工资也将被收集。这将用于投影 护士或护士技术员在患者接触方面的潜在改进和潜在的成本节约 CBOC中的门诊患者DES EEG与VAMC中执行门诊SES EEG的EEG技术人员。