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：许多退伍军人生活远离具有大量脑电图的VAMC（EEG） 专业知识。对于癫痫患者而言，旅行很困难，因为他们经常无法开车。我们建议研究一种新颖的干燥 电极系统（DES）不需要脑电图技术人员操作，并且可以由护士操作 助手。这将电极和脑电图放大器整合到紧凑的耳机中，很容易放置 在头部（没有皮肤准备），可以在癫痫远程医疗外展计划中使用 进行临床访谈。我们已经使用DES耳机进行了三项初步研究。在我们的前两个 对在VAMC进行的33名退伍军人进行的研究，我们发现DES快速应用，仅占5-6 在神经科医生的协助下，由研究主题插入的几分钟。受试者更喜欢DES 标准脑电图系统（SES）上的耳机。在我们的第三项研究中，护士在VA中进行了30张DES录音 基于社区的门诊诊所（CBOC）。脑电图记录的评级为五点比例。 经过认证的临床脑电图专家（将自动脑电图减少后，录音应用于录音） 所有30张录音都具有可接受的质量（在5分或更高的额定值中，有一些人工制品）和18 在30个记录中，质量良好（速率为4或以上，只有较小的人工制品）。 重大影响：这项研究将改善在农村地区生活的退伍军人的进入 癫痫患者护理的重要诊断程序：常规脑电图。能够表演 CBOC中的常规脑电图可以降低VA系统的成本，因为DES EEG系统价格较低，并且 因为退伍军人不必前往VAMC进行脑电图。这项研究还将测试DES系统以制造 当然，它可以记录癫痫样瞬态（ETS），这表明患者患有癫痫病。 创新：这项研究具有创新性 赞同。这个新的DES EEG记录系统提供了一种录制脑电图的方法，该方法更便宜，并且 比传统的脑电图更容易执行。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ETS。 （DE系统的FDA批准是基于脑电图信号 仅质量，而不是它是否可以可靠地检测到ET。）该研究还将使用新的FDA批准方法 为了自动删除可能掩盖des eeg记录的人为信号。 具体目的：该项目的第一个目的是测试DES记录ETS与SES的能力。这 第二个目的是收集有关约会等待时间的数据，约会取消率和程序成本的 DES与SES预测退伍军人访问权限和DES EEG的潜在成本效益的改善 在CBOC与在VAMC中进行的SES EEG进行。 方法论：这是一个随机对照试验，将在三个地点进行：查尔斯顿 VAMC，Durham VAMC和Miami VAMC。对于特定的目标1，400名退伍军人（200例异常病史 记录了ET的脑电图，并安排有200名为门诊脑电图的前瞻性退伍军人） 在一次研究访问期间执行的des eeg程序和SES脑电图的招募。 脑电图技术专家的VAMC。每个脑电图记录都将被解释和评级为技术质量三个 研究研究人员还将注释每个脑电图记录中ETS的位置。脑电的比例 该证明ETS和技术质量评级将被比较。对于特定目标2，数据将是 收集了安排门诊常规脑电图的300名准退伍军人，包括预约 取消率，旅行成本和其他患者因素。 EEG设备/耗材以及技术人员的成本 还将收集努力/薪水和护士和护士助理/工资。这将用于投影 表演护士或护士技术人员的患者访问和潜在成本的潜在改善 CBOC中的门诊病人与脑电图技术人员在VAMC中进行门诊SES EEG。