Saint Francis plans to enroll up to 20 patients in the study, which will evaluate the safety and effectiveness of the Bioness® StimRouter™ Neuromodulation System, a targeted treatment designed to relieve chronic neuropathic pain of peripheral origin. Dr. Timothy Deer of The Saint Francis Hospital Center for Pain Relief is the study’s medical monitor, and principal investigator for this study at St. Francis.
“20 million individuals in the United States suffer from chronic peripheral nerve pain, which can have a dramatic impact on quality of life. Historically, we have had few treatment options other than the use of pharmaceutical therapy – most often narcotics, which affect the whole body and have many undesirable side-effects,” said Timothy Deer, MD, pain management specialist at The Center for Pain Relief at Saint Francis Hospital in Charleston, West Virginia. “The StimRouter could potentially provide – for the first time – a non-pharmaceutical treatment option that can be targeted directly to the pain site for more focused pain relief. The results of this study could have a significant impact on the way we treat patients with peripheral nerve pain.”
The StimRouter System, developed by Bioness, Inc., consists of an implanted lead that delivers low-level electrical impulses directly to the nerve that carries the pain signal. The lead is the only component of the StimRouter that is implanted. An External Pulse Transmitter (EPT) worn outside the body sends electrical signals through the skin to the implanted lead. The EPT can store stimulation programs and provide patients with a variety of treatment options depending on their activity or level of pain.
This prospective, multi-center, randomized, double-blinded, partial crossover study will enroll 126 patients at up to 10 study sites throughout the U.S. The study is expected to last for 30 months, with each study participant receiving treatment and evaluation for a total of 13 months. Several secondary endpoints such as changes in pain medication, quality of life, patient impression of improvement with treatment, change in worst pain, interference of pain with physical and emotional functioning, patient satisfaction and long-term safety will also be evaluated as part of this study.
According to centerforpainrelief