Miniature Stimulator for Temporary Therapies

DESCRIPTION (provided by applicant): The goal of this project is to collect the safety and effectiveness clinical data necessary to commercialize the SMARTPATCH(R) system for post-stroke shoulder pain (PSSP). The prevalence of stroke is approximately 8 million in the US, with 795,000 additional persons surviving a stroke each year. Moderate to severe shoulder pain develops in a quarter to a third of stroke survivors, amounting to a current population of over 2 million. Existing interventions have limited effectiveness, limited duration of benefit, and/or significant burden. Our team developed percutaneous peripheral nerve stimulation (PNS) delivered via our innovative Smartpatch system for the treatment of PSSP, which addresses the limitations of existing interventions. Of 60 subjects who received temporary percutaneous PNS therapy across multiple studies, 75% experienced clinically significant pain relief during stimulation, with a third becoming completely pain free. The majority of subjects reported