As patients, physicians, and medical technology companies try to find non-narcotic solutions to chronic pain, two new devices have emerged that have some potential. One is a high-frequency spinal cord stimulator for the treatment of chronic pain, while the other is a repetitive transcranial magnetic stimulation (rTMS) device for fibromyalgia pain relief.
Nevro’s Senza High-Frequency Spinal Cord Stimulator
This month the Nevro Corp, a privately held medical device company headquartered in Menlo Park, Calif., announced that the Food and Drug Administration (FDA) has granted approval for a study of its Senza High-Frequency Spinal Cord Stimulation (HF-SCS) System. The system is unique in that it is capable of delivering higher rates of electrical pulses for spinal cord stimulation than any device currently available – and can do so without unpleasant side effects, according to Nevro.
“There is a real, unmet need for additional treatment options for chronic pain patients,” said Leonardo Kapural, MD, medical director of Wake Forest University Health Sciences, Chronic Pain Center in Winston-Salem, N.C., who serves as the principal investigator for the SENZA-RCT trial. “Early studies suggest that high-frequency spinal cord stimulation may expand the group of patients treatable with spinal cord stimulation.”
Approximately 300 patients will be enrolled in up to 15 U.S. locations in the FDA-approved study. Patients will be randomly assigned to either a conventional low-frequency spinal cord stimulator or Nevro’s high-frequency stimulator.
Previous European clinical studies indicate that Nevro’s high frequency technology may be an effective treatment for low back pain and other chronic pains that do not typically respond to traditional spinal cord stimulation. Data also shows that the Senza stimulator can deliver pain relief without paresthesia, an unpleasant buzzing or tingling sensation that is a common side effect of conventional stimulators.
“Results from this initial clinical study suggest high-frequency spinal cord stimulation may be effective in patients who have debilitating back pain, a group that is typically very difficult to treat,” said Jean-Pierre Van Buyten, MD, chairman of the Multidisciplinary Pain Center AZ Nikolaas Sint-Niklaas, Belgium. “Nevro’s treatment has allowed many of my patients to go from bed rest to a more active life.”
While authorized for sale in Australia and Europe, Nevro’s Senza HF-SCS System is limited to investigational use in the United States.
Cervel Neurotech’s TMS Device
An experimental transcranial magnetic stimulation (TMS) device developed by Cervel Neurotech produced sustained and effective pain relief when tested in a small pilot study of five fibroymaligia patients. Repetitive transcranial magnetic stimulation uses magnetic fields to promote electrical currents within the brain and give pain relief.
The new device is comparable to a TMS device marketed by NeuroStar, which used for treating depression. But while the NeuroStar device uses a single coil to create electrical current and a pulsating magnetic field, Cervel’s new device is designed with four-coils to target deeper areas of the brain.
During the four-week study, a steady decrease in pain levels was seen in all five patients who used the device. An average 45 percent drop in pain was seen at the four-week follow-up point. There were a few adverse side effects, including mild episodes of nausea, scalp pain, and headache.
“Some of the patients had complete pain relief, while others less so,” said Dr. M. Bret Schneider, a psychiatrist and neurosurgeon at Stanford University who is the founder of Cervel Nuerotech.
A larger, controlled study of about 40 fibromyalgia patients is the next step in evaluating the device’s effectiveness. Cervel Neurotech funded and conducted the initial study