FDA approves pivotal study of Smartpatch Peripheral Nerve Stimulation System for post-stroke shoulder pain


The US Food and Drug Administration has given investigational device exemption (IDE) approval to SPR Therapeutics to initiate a multicentre, pivotal study to evaluate the safety and effectiveness of the Smartpatch Peripheral Nerve Stimulation (PNS) System for the treatment of post-stroke shoulder pain. 

According to the Post-Stroke Rehabilitation Outcomes Project, shoulder pain has been found to affect one third of post-stroke survivors, most describing their pain as moderate to severe. The Smartpatch PNS System offers a medical device pain relief therapy that has the potential to be an alternative to pain medications, and their accompanying side-effects. 

John Chae, professor of Physical Medicine and Rehabilitation at Case Western Reserve University and MetroHealth Medical Center, USA, said: “The Smartpatch PNS System has provided significant pain relief and improvement in quality of life in earlier studies, and if similar results are achieved in this pivotal trial, it will offer a much needed treatment for patients who have very limited options at present. Perhaps most interesting is that unlike any other neurostimulation technology I am aware of, Smartpatch is designed to offer pain relief that persists even after the short-term therapy has ended. Smartpatch holds the potential to alleviate debilitating shoulder pain and to provide an alternative to pain medications.”  

The Smartpatch PNS System utilises a single percutaneous lead wire connected to a small skin-mounted stimulator to provide peripheral nerve stimulation for up to 30 days. The lead wire is withdrawn and the stimulator removed at the end of the treatment. 

SPR Therapeutics will soon initiate a recruitment campaign to enrol study participants in the following cities:

  • Charlotte, North Carolina
  • Chicago, Illinois
  • Cleveland, Ohio
  • Columbus, Ohio
  • New York, New York
  • Philadelphia, Pennsylvania
  • West Orange, New Jersey

Individuals interested in being considered as candidates for the study can visit www.painafterstroke.com