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 million in the US with 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 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 subjects who received temporary percutaneous PNS therapy across multiple studies experienced clinically significant pain relief during stimulation with a third becoming completely pain free The majority of subjects reported sustained pain relief for at least weeks after stimulation was turned off and many had sustained relief beyond one year The objective of this project is to execute a prospective randomized double blinded placebo controlled multicenter pivotal trial in support of US FDA regulatory clearance Subjects will be randomized to either a treatment group in which percutaneous PNS is delivered for weeks or a control placebo group in which the percutaneous lead is placed in the same location and the subject is asked to use the system for weeks but no stimulation is delivered The specific aims of this project are to Demonstrate the clinical effectiveness of the Smartpatch system in reducing post stroke shoulder pain Demonstrate the clinical effectiveness of the Smartpatch system in improving quality of life and Demonstrate the carry over effect of the Smartpatch system at weeks post treatment Upon successful completion of the pivotal trial we will submit a k application to the FDA to obtain US market clearance for the Smartpatch system Commercialization of the Smartpatch system will change how pain is managed by providing a drug free short term minimally invasive simple reversible safe and effective treatment option resulting in long term pain relief and an improvement in the QOL of millions of US stroke survivors suffering from moderate to severe shoulder pain PUBLIC HEALTH RELEVANCE Each year in the United States almost one third of the new stroke survivors develop shoulder pain most describing their pain as moderate to severe The treatment of shoulder pain is an important step towards recovery for stroke survivors as shoulder pain has been found to interfere with therapeutic exercises lengthen the time to recovery produce insomnia and require additional medications or interventions during rehabilitation We propose to conduct a clinical study on a novel therapy that uses electrical stimulation to treat post stroke shoulder pain