Wearable EMG-FES System for Stroke Rehabilitation and Biomarker Development - PROJECT SUMMARY For the nearly 800,000 people in the U.S. who suffer a new or recurrent stroke each year, more than 60% are left with a unilateral weakness, or hemiparesis, affecting their arms, wrists, or hands. Physical rehabilitation remains the gold standard for improving motor function after stroke. Despite our best efforts, however, more than 80% of people fail to regain complete function in their affected arm despite months of conventional physical rehabilitation. New therapy systems are needed that can enhance the synchronized activation of the nervous system and muscle tissue, via top-down and bottom-up pathways, which is essential for functional recovery after stroke. In recognition of this need, the research team (consisting of collaborators from The Ohio State University, Battelle Memorial Research Institute, and The University of Texas at Dallas) have developed a sleeve-based functional electronic stimulation (FES) system, called the NeuroLife Sleeve, that triggers stimulation from the user’s own intent, via surface electromyography (EMG). The system is unique because: (i) it is a sleeve, which is easy to don and doff; (ii) it has 150 dual sensor/FES electrodes embedded in the sleeve, which eliminates the time needed to manually place electrodes each time a new movement pattern is needed; and (iii) the electrodes are hybrid, meaning they allow for concurrent recording of muscle activation and intent (via EMG) and FES delivery. This dual functionality makes the system uniquely capable of both sensing motor intent and delivering targeted, closed-loop stimulation. The team’s published and pilot data demonstrate the feasibility of using the NeuroLife Sleeve system to improve functional upper-limb recovery after stroke. The system, however, is a research-grade prototype that is poorly adapted to independent clinical use by an occupational therapist (OT). Thus, the overarching goal of this two-phased project is to refine the system’s clinical interface and workflow, integrating user-informed software updates, streamlined calibration, and therapist-facing training materials, to ensure the system can be independently, quickly, and reliably operated by an occupational therapist in a clinical setting. If successful, the follow-on phase of research will support an early-stage randomized controlled clinical trial (RCT) of the redesigned system (vs. standard FES therapy) in a group of 30 people with hemiparesis due to stroke who are undergoing rehabilitation to improve their upper-arm function. The RCT will use a battery of well-defined upper-arm tests in stroke to evaluate early efficacy of the new system, as well as look at its usefulness as a wearable orthosis. Finally, extending from the team’s recent publications looking at the high- density EMG features that are captured by the NeuroLife system, data collected from the RCT will be analyzed to discover new EMG-derived biomarkers of neuroplasticity and recovery after stroke. Thus, this project builds upon years of preclinical and clinical research in stroke rehabilitation and neuromodulation to advance both the underlying technology and our mechanistic understanding of the effects of stroke and the pathways to upper- limb rehabilitation.
