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

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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.