SPR Therapeutics, Cleveland, Ohio, and parent company NDI Medical, headquartered in Cleveland, have received a $2.77 million Peer Reviewed Orthopaedic Research Program Clinical Trial Award to advance SPR’s peripheral nerve stimulation (PNS) therapy to relieve residual limb pain and/or phantom limb pain. The research grant is from the U.S. Department of Defense (DOD) office of the Congressionally Directed Medical Research Programs (CDMRP), which supports “military-relevant, peer-reviewed orthopedic research.”
The grant will support the next phase of the clinical research for SPR’s PNS system, the SMARTPATCH®, which uses a minimally invasive proprietary method of nerve stimulation in which small pulses of electrical stimulation are delivered to nerves in the residual limb. The system consists of a skin-mounted external stimulator, percutaneous lead, and small adhesive pads that contain the power source. This therapy is intended to produce a comfortable sensation where pain is felt and decrease or eliminate the perception of pain. The research will be conducted by research teams at the Center for Clinical Research, Winston-Salem, North Carolina, and Walter Reed National Military Medical Center, Bethesda, Maryland.
According to the funding proposal, the specific aims of this project are to determine if this therapy results in a clinically significant reduction in post-amputation pain, if the therapy delivered by the implantable system results in sustained clinically significant pain relief, and if the therapy improves functional outcomes. The external Smartpatch system will be used with subjects to conduct a trial of the therapy. Subjects with clinically significant pain relief will receive a fully implantable MICROPULSE® system for long-term therapy. The ultimate goal of this research is to make a safe and effective treatment for post-amputation pain available to the U.S. military that will optimize recovery and restoration of physical functioning after major limb amputation.
According to SPR, the grant award is a result of the successful completion of its post-amputation pain feasibility study in which the majority of study participants receiving the temporary therapy-a precursor to the Smartpatch-reported substantial pain relief as well as improved quality-of-life outcomes. These early results were published in May in the journal Pain Practice.
“For those who have undergone amputation, pain, rather than the loss of a limb, is frequently what most negatively impacts their daily lives and prevents their return to active duty or employment,” said principal investigator Richard Rauck, MD, director of the Center for Clinical Research. “I’m eager to support this next phase of the research to advance the therapy…. There are thousands of military personnel and civilian candidates seeking an effective solution for post-amputation pain.”
Editor’s note: SPR’s Smartpatch and Micropulse Systems are investigational devices that are limited by federal law to investigational use. To learn more about the study, e-mail [email protected]