Single Center, Single-Group Trial to Evaluate the Safety and Feasibility of 50 Hz Stimulation to Enhance Stroke Recovery of Upper Limb Function: The Motor Recovery Through Plasticity-Inducing Cortical Stimulation Open-Loop Protocol

BACKGROUND AND OBJECTIVES: trial) of epidural cortical stimulation showed improved rehabilitation outcomes in a subset of those with poststroke related disability as long as (1) the individual had a degree of surviving corticospinal tracts and (2) an electrode that when delivering stimulation could evoke a motor response. The goal of this study is to examine the safety and feasibility of new sense-and-stim capable implantable devices with configurable electrode arrays, using subdural stimulation, to improve stroke rehabilitation and associated motor functional outcomes. METHODS: We will implant 4 patients who have chronic upper limb impairment after stroke to (1) demonstrate the safe usage of a cortical sensing-enabled stimulation system in a stroke rehabilitation protocol and (2) evaluate the system's capability to deliver activity-triggered stimulation for future clinical studies using neuroplasticity-inducing stimulation to enhance stroke rehabilitation outcomes. Each participant will receive 50 Hz stimulation delivered through the cortical, subdural, electrodes during clinical rehabilitation visits for 2 hours a day, 5 days a week, for 6 weeks. Devices are explanted approximately 9 months after implant. EXPECTED OUTCOMES: We anticipate that the surgical implantation of the cortical stimulation device and use of the device to deliver stimulation to enhance rehabilitation outcomes will succeed without identifying unanticipated safety concerns or encountering unexpected adverse events. DISCUSSION: Although the generalizability of the results will be limited based on the small number of study participants, it is nonetheless a crucial research milestone for reestablishing cortical stimulation as a potential method for enhancing poststroke rehabilitation.