A Fully Remote Telehealth Brain Computer Interface And Assessment System For Motor Rehabilitation Of Chronic Stroke

抽象的。大量未得到满足的临床需求和巨大的商业机会集中在慢性中风患者的 难以获得高级康复护理[1，2]。在康复慢性运动受损的中风幸存者方面 有了脑机接口(BCI)，BCI驱动的远程医疗进一步发展的当前障碍 神经康复是没有集成的软件和硬件系统，可以轻松地部署到 在家庭环境中筛选、治疗和跟踪慢性中风患者。我们公司Neurolutions‘s Long- 本研究的长期目标是创建一种可广泛扩展的BCI康复解决方案，该解决方案可以恢复 患有慢性中风引起的运动障碍的患者。因此，创建和审查技术基础设施以实现 远程采集/分析患者的大脑信号及其运动功能对于实现这一目标至关重要。 这项提议的目标是创建一种通过邮件递送、连接互联网的系统，使基于家庭的 脑电筛查BCI-康复候选和远程运动评估上肢对BCI- 康复治疗。我们的中心假设是完全远程评估、登记和治疗慢性病 使用脑机接口控制的机器人手外骨骼治疗上肢运动障碍的中风患者 将显示出手功能的显著改善。因此，其基本原理是使患者能够 在家中进行有效的筛查、治疗和监测，消除了患者前往医疗保健的需要 环境，从而使更多的人能够使用这项技术。具有丰富的经验 在卒中脑机接口和以家庭为基础的护理[3]方面，我们已做好充分准备，与 具体目标如下：1)为慢性中风患者创建基于家庭的脑电筛查系统，以确定 上肢运动障碍BCI康复的候选资格，2)创建以家庭为基础的系统 身体运动评估，相当于标准的面对面Fugl-Meyer(FM)评估 末端函数，3)对照金标准定义基于家庭的Fugl-Meyer(FM)评估的准确性 面对面FM评估，以及4)定义完全远程家庭BCI治疗在慢性疾病中的疗效 偏瘫皮质下卒中患者。这个项目是创新的，因为1)它代表着与 通过扩大未受影响的大脑半球在BCI介导的卒中康复中所能发挥的作用 2)将重点放在全程治疗(筛查、治疗和监测)上 背离了先进的BCI中介康复如何提供的商业模式。这个项目将 利用Neurolutions BCI核心康复技术IpsiHand，该技术最近获得了 FDA突破性的设备指定。拟议的研究将具有重要意义，因为 一个可以远程评估和治疗慢性中风患者的集成系统将从根本上增加访问 并为这一未得到充分服务的人群中更大比例的人提供治疗益处。总的来说，成功的 该项目的实施将减轻数百万美国人中风的个人和社会负担。

Abstract. A substantial unmet clinical need and large commercial opportunity centers on chronic stroke patients’ poor access to advanced rehabilitation care [1, 2]. In rehabilitating chronically motor-impaired stroke survivors with a brain computer interface (BCI), the current barrier for further advancement of telehealth BCI-driven neurorehabilitation is that there is no integrated software and hardware system that is easily deployable to screen, treat, and track chronic stroke patients in their home environments. Our company Neurolutions’ long- term goal of this research is to create a widely scalable BCI rehabilitation solution that can restore function to patients with a chronic stroke-induced motor deficit. Thus, creating and vetting a technical infrastructure to enable remote acquisition/analysis of a patient’s brain signals and their motor function is essential to achieving this goal. The objective of this proposal is to create a mail-delivered, internet-connected system that enables home-based EEG screening for BCI-rehab candidacy and remote motor assessment of upper extremity response to BCI- rehab treatment. Our central hypothesis is that fully remote assessment, enrollment, and treatment of chronic stroke patients with an upper extremity motor deficit with the use of a BCI-controlled robotic hand exoskeleton will demonstrate significant improvement in hand function. Thus, the rationale is that enabling patients to be effectively screened, treated and monitored at home removes the need for patients to travel to health care environments and thus enables a much larger population to access this technology. With extensive experience in stroke-BCI and home-based care [3], we are well prepared to pursue the objective of this proposal with the following Specific Aims: 1) Create a home-based EEG screening system for chronic stroke patients to determine candidacy for BCI rehabilitation of upper extremity motor deficit, 2) Create a home-based system for performing physical motor assessments that are equivalent to standard in-person Fugl-Meyer (FM) assessment of upper extremity function, 3) Define the accuracy of home-based Fugl-Meyer (FM) assessment against gold standard in-person FM assessment, and 4) Define the efficacy of fully remote home-based BCI therapy in chronic hemiparetic subcortical stroke patients. This project is innovative because 1) it represents a departure from the status quo by expanding the role the unaffected hemisphere can play in BCI-mediated stroke rehabilitation and 2) the focus on full course of treatment (screening, treatment and monitoring) occurring in the home significantly departs from the commercial models of how advanced BCI-mediated rehabilitation is delivered. This project will leverage the core Neurolutions BCI rehabilitation technology, the IpsiHand, which was recently given a Breakthrough Device designation by the FDA. The proposed research will be significant because the creation of an integrated system that can assess and treat chronic stroke patients remotely will radically increase access and therapeutic benefit to a much larger percent of this underserved population. Collectively, the successful execution of this project will reduce the personal and social burden of stroke for millions of Americans.