NSF/FDA SIR: Robust, Reliable, and Trustworthy Regulatory Science Tool for Stroke Recovery Assessment using Hybrid Brain-Muscle Functional Coupling Analysis

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Stroke is the leading cause of age-related motor disabilities and is becoming more prevalent in younger populations. The development of post-stroke motor rehabilitation technologies is at an all-time high. Many of these technologies claim to accelerate recovery. However, subjective and coarse evaluation of motor capacities have generated inconsistent recommendations regarding rehabilitation devices. There is a need for the development of a robust, reliable, and accessible biomarker for post-stroke recovery. Such a biomarker could be used as a regulatory science tool (RST) that improves the Food and Drug Administration (FDA) review process for rehabilitation device applications. This proposal focuses on the design and validation of a robust and high-fidelity marker of recovery, considering the directional information exchange between regions of the central and peripheral nervous systems. There is currently no approved RST for assessing the efficacy of rehabilitative devices for post-stroke motor recovery. This research is a collaboration between New York University and the FDA, and represents a unique joint effort from the clinical, engineering, and regulatory sectors. The project will include seminars and undergraduate research to promote STEM education with a focus on engaging students from underrepresented groups.The central goal of this project is to implement a noninvasive biomarker that demystifies the directional (afferent and efferent), nonlinear, and complex patterns of neural communication, realizing a “neurophysiological magnifier” that objectively quantifies degradation in the interaction between anatomy, activation, and pathway in post-stroke patients. The project will analyze the reliability and efficacy of the proposed biomarker based on data acquired from recovering stroke patients with the goal of developing the first-ever stroke-focused rehabilitation RST. For this, the project (1) proposes a mechanistic view of the modulations of afferent and efferent neural pathways in correlation with motor performance and mobility, (2) quantifies the cortical sources involved in sensorimotor processing after stroke and their connectivity to the motor units in muscles, (3) establishes corticomuscular biomarkers that predict motor performance and mobility for stroke patients, and (4) performs inter-and intra-subject reliability analyses in addition to validation analyses using independent datasets. This project will also promote FDA regulatory science on next-generation brain-machine interfaces.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.