SPR Therapeutics, Cleveland, has received a $1.45 million grant from the National Institutes of Health (NIH) to develop a fully implantable peripheral nerve stimulation (PNS) system to treat post-amputation pain and other types of neuropathic pain conditions. The small business innovation research (SBIR) phase II grant complements a $2.8 million research grant from the U.S. Department of Defense that is funding ongoing clinical trials to assess the safety and efficacy of SPR’s PNS therapy in the management of phantom limb and residual limb pain following amputation.
SPR’s approach to PNS involves the percutaneous insertion of a very small medical wire, or lead. Ultrasound guidance is used to position the lead remote from the nerve, decreasing risk of nerve injury and making the procedure amenable to the interventional pain management physician, the company said. Placement of the lead remote to the nerve also allows the system to activate the targeted sensory nerve fibers without activating pain or motor fibers. Conventionally, PNS has involved the placement of multiple electrodes in close proximity to the nerve, often requiring a neurosurgical procedure to dissect tissue from around the nerve, according to SPR.
The NIH grant will be used to develop SPR’s second-generation implantable pulse generator (IPG) for patients who require long-term stimulation to manage their chronic pain following amputation and other types of neuropathic pain conditions. Currently available IPGs are typically implanted in the trunk or abdomen. The planned project will result in development of a small implantable device that can be comfortably placed within the residual limb of an individual with an amputation.
“Access to this technology opens the door to the treatment of many currently unaddressed chronic peripheral pain conditions, such as post-amputation pain, for which appropriate treatment options do not exist,” said interventional pain physician Steven P. Cohen, MD, director of pain research at Walter Reed National Military Medical Center, Bethesda, Maryland; professor of anesthesiology & critical care medicine and physical medicine & rehabilitation at Johns Hopkins School of Medicine; and a professor at the Uniformed Services University of the Health Sciences, Bethesda.
