Bioness® StimRouterTM Peripheral Nerve Stimulator Study
Bioness StimRouter Study at Arizona Pain Specialists involves investigating an investigational peripheral nerve stimulator for the treatment of peripheral neuralgia. This device consists of a small lead implanted under the skin as well as an external pulse transmitter and battery, which are attached to the skin.
Peripheral neuralgia refers to chronic pain of the arms, legs, or trunk caused by damage to the nerves themselves. This condition can result from various causes, including physical trauma or surgical procedures, and is often difficult to treat. This study tests one method that has previously found to be effective for treating peripheral neuralgia – peripheral nerve stimulation. In peripheral nerve stimulation, pain is reduced by delivering non-painful electrical stimulation to the nerve that is the source of an individual’s pain. This stimulation interferes with the pain signals from the affected nerve, resulting in a reduction in perceived pain.
The Bioness® StimRouterTM relies on the same principle as a spinal cord stimulator. Spinal cord stimulators are used for individuals experiencing pain from multiple nerves, as the spine is a central route for pain. The StimRouterTM is designed for individuals experiencing pain originating in a single nerve of the arms, legs, or trunk.
Patients who qualify for this study will have the StimRouterTM implanted near the site of their pain and programmed two to four weeks later. For the first 12 weeks of this study, some patients will receive the treatment stimulation while others receive only control stimulation. However, for the remaining nine months of the study, all patients will receive the treatment stimulation. Patients will have five screening visits over the course of 13 months to assess the devices safety and efficacy at reducing their pain.