Early tests are raising hopes that a new device can help people who’ve injured their spinal cord.
Implantation of an oscillating field stimulator, which generates an electrical field, is a safe, well-tolerated treatment that may improve motor and sensory function in such patients, findings from a pilot study suggest.
The device, which was developed at Purdue University, is placed near the site of injury and is designed to stimulate nerves to regenerate and, it’s hoped, restore some degree of function.
After seeing encouraging results in dogs with spinal cord injury, Dr. Scott Shapiro, from Indiana University School of Medicine, Indianapolis, and colleagues tested the device in humans. The researchers’ findings appear in the Journal of Neurosurgery-Spine.
The early-stage trial involved 10 patients with a complete spinal cord injury but no evidence on an MRI scan that the nerves had been actually severed.
Average pain-scale scores were 8 at the time the device was implanted. After six months, the scores had dropped to 2, and in most patients remained there after a year.
Treatment with the oscillating field stimulator was associated with significant improvements in sensitivity to light touch, pinprick sensation and motor function.
“This isn’t a home run, but it warrants additional investigation,” Schapiro said in a statement. “The big question was whether the procedure, which is very invasive and requires two surgeries, is efficacious and the initial results indicate that it is.”
Based on these findings, the US Food and Drug Administration has approved another trial of the device, which should begin early this year, the researchers note.
SOURCE: Journal of Neurosurgery-Spine