The FDA approves SPR Therapeutics to initiate a multi-center, pivotal study of the Smartpatch Peripheral Nerve Stimulation that treats people with post-stroke shoulder pain.
According to the Post-Stroke Rehabilitation Outcomes Project, 33% of stroke survivors have moderate to severe shoulder pain. The Smartpatch uses a single percutaneous lead wire that connects to a small stimulator mounted on the skin to provide nerve stimulation for up to 30 days. The wire and stimulator are withdrawn after treatment.
According to a statement from SPR Therapeutics, a developer in applying electrical stimulation to peripheral nerves, Smartpatch relieves pain, even after the short-term therapy is over.
“Smartpatch holds the potential to alleviate debilitating shoulder pain and to provide an alternative to pain medications,” says Dr. John Chae, professor of Physical Medicine and Rehabilitation at Case Western Reserve University and MetroHealth Medical Center.
According to the statement, study participants tolerate the treatment well, experience significant pain relief, and average a 63% reduction in pain 12 weeks after treatment.
"Our studies thus far suggest that significant pain relief may be achieved and that it may continue after the short-term therapy has ended," says Maria Bennett, president and CEO of SPR Therapeutics. "The FDA approval to proceed with the pivotal trial gives us the opportunity to gather additional data from this randomized, double-blinded, placebo-controlled study to evaluate pain relief and other potential benefits of the SMARTPATCH PNS System and to seek FDA clearance. We are excited to get this study underway and to make the therapy available to patients."
SPR Therapeutics will soon initiate a recruitment campaign to enroll 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