Spinal Modulation, Inc., has announced the first patient enrollment in its U.S. pivotal clinical trial. The ACCURATE Study is a prospective, randomized, multi-center, controlled trial that will evaluate the safety and efficacy of the Axium™ Neurostimulator System for the treatment of chronic lower limb pain.
Chronic neuropathic pain is a condition that affects millions of people, impacting their ability to lead productive working, social and family lives. Neuropathic pain is induced by an injury or disease of the nervous system and the most common location is the lower limbs including areas such as the legs, feet, and groin area. Patients suffer from a wide variety of pain sensations including stabbing, burning, pins and needles, and numbness.
Spinal Modulati0n’s Axium Neurostimulator System is the only form of spinal cord stimulation (SCS) that targets a specific branch of the spinal cord called the dorsal root ganglion (DRG). The DRG contains the primary sensory neurons that transmit pain signals from the peripheral nerves to the brain. The system uses an implantable medical device to deliver mild electrical pulses to the DRG. These pulses mask or interrupt pain signals as they travel to the brain. The Axium Neurostimulator System has CE Mark in the European Union and TGA approval in Australia for the management of chronic, intractable pain, although as yet it remains investigational in the United States.
The ACCURATE Study is designed to evaluate the safety and efficacy of Spinal Modulation’s Axium Neurostimulator System for the treatment of chronic pain affecting the lower limbs. Inclusion criteria are age 22 to 75 years, chronic pain affecting lower limbs for at least 6 months, no lasting success with other treatments and no previously used spinal cord stimulation for chronic pain.
“This is a landmark study in the field of spinal cord stimulation,” said Eric Grigsby, M.D., founder and medical director of the Napa Pain Institute and the center’s principal investigator. “The Axium System targets the dorsal root ganglion (DRG), a unique branch of the spinal cord that plays a critical role in the development and maintenance of chronic pain1. The recently published European data2 from a non-randomized study are promising – 78 percent of patients experienced pain relief in the lower limbs. I am excited to be the first in the country to participate in this important clinical trial.” The study is expected to enroll 152 patients in up to 25 medical centers in the U.S.
Source: Spinal Modulation, Inc., Business Wire