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

抽象的。大量未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治疗上。 获得先进的康复护理的机会少[1，2]。在康复慢性运动障碍的中风幸存者 与脑机接口（BCI），目前的障碍，进一步发展远程保健BCI驱动的 神经康复是没有集成的软件和硬件系统，可以很容易地部署， 在家中筛查、治疗和跟踪慢性中风患者。我们公司Neurolutions的长期- 本研究的长期目标是创建一个可广泛扩展的BCI康复解决方案， 患有慢性中风引起的运动缺陷的患者。因此，建立和审查技术基础设施， 远程获取/分析患者的脑信号及其运动功能对于实现该目标是必不可少的。 这项建议的目的是建立一个邮件传递，互联网连接的系统，使家庭为基础的 BCI康复候选人的EEG筛查和上肢对BCI反应的远程运动评估- 康复治疗我们的中心假设是，完全远程评估，招募和治疗慢性 使用BCI控制的机器人手外骨骼治疗上肢运动缺陷的中风患者 会在手部功能上有显著改善因此，理论基础是使患者能够 在家中进行有效的筛查、治疗和监测，使患者无需前往医疗保健机构 环境，从而使更多的人能够获得这项技术。具有广泛经验的 在脑卒中BCI和家庭护理[3]中，我们已经做好了充分的准备， 以下具体目标：1）为慢性中风患者创建一个基于家庭的EEG筛查系统，以确定 上肢运动缺陷的BCI康复的候选资格，2）创建一个基于家庭的系统， 身体运动评估，相当于标准的Fugl-Meyer（FM）评估， 肢体功能，3）根据金标准定义家庭Fugl-Meyer（FM）评估的准确性 亲自FM评估，以及4）定义完全远程基于家庭的BCI治疗在慢性 偏瘫皮层下中风患者。这个项目是创新的，因为1）它代表了一个背离 通过扩大未受影响的半球在BCI介导的中风康复中的作用， 2)注重在家中进行的整个治疗过程（筛查、治疗和监测）， 背离了如何提供高级BCI介导的康复的商业模式。该项目将 利用核心Neurolutions BCI康复技术IpsiHand，该技术最近获得了 FDA的突破性器械认定。拟议的研究将是重要的，因为创建 一个可以远程评估和治疗慢性中风患者的综合系统将从根本上增加访问 和治疗上的好处。总的来说，成功的 该项目的实施将减少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.