User presses button to release pulse of magnetic energy that may help ease headache
SUNDAY, Dec. 15, 2013 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first device aimed at easing the pain of migraines preceded by aura -- sensory disturbances that occur just before an attack.
The Cerena Transcranial Magnetic Stimulator would be obtained through prescription, the FDA said in a statement released Friday. Patients use both hands to hold the device against the back of their head and press a button so that the device can release a pulse of magnetic energy. This pulse stimulates the brain's occipital cortex, which may stop or ease migraine pain.
"Millions of people suffer from migraines, and this new device represents a new treatment option for some patients," Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in the statement.
The agency's approval is based on a trial involving 201 patients who had suffered moderate-to-strong migraine with aura. One hundred and thirteen of the patients tried treating their migraines while an attack was in progress, and it was the testimony of this group that led to the approval of the new device, the FDA said.
More than a third (38 percent) of people using the stimulator said they were pain-free two hours later, compared to 17 percent of patients who did not use the device. A full day after the onset of migraine, nearly 34 percent of device users said they were pain-free, compared to 10 percent of people who hadn't used the device.
Two experts welcomed the news of the approval.
"The Cerena TMS is another tool in the battle to relieve migraines," said Dr. Mark Green, director of Headache and Pain Management at the Mount Sinai Medical Center in New York City. "Experience with TMS over the past few years have shown that these agents have the potential to reduce the pain of an attack without the use of medications, or in addition to medical treatment."
Dr. Noah Rosen is director of the Headache Center at North Shore-LIJ's Cushing Neuroscience Institute, in Manhasset NY. He said that, "although only 20 percent of migraneurs suffer from an aura associated with their headaches, they suffer significantly. Although this device is unwieldy, it may be a preferred choice by those who don't want [drug] treatment."
Side effects from the device were rare, the FDA said, but included "single reports of sinusitis, aphasia (inability to speak or understand language) and vertigo."
The new device is approved only for use by those aged 18 or older, and should not be used by people with suspected or diagnosed epilepsy or a family history of seizures. It should also not be used by anyone with any metal device implanted in the head, neck or upper body, or by people with "an active implanted medical device such as a pacemaker or deep brain stimulator," the FDA said.
The stimulator, manufactured by eNeura Therapeutics of Sunnyvale, Calif., is not meant to be used more than once every 24 hours, the FDA added. It has also not been tested to see if it is effective against other symptoms of migraine such as nausea or sensitivities to light or sound.
Green called that last point "disappointing," and added that "the other concern is whether insurance carriers will make the product available [to patients]."
Find out more about migraine with aura at the American Headache Society (http://www.americanheadachesociety.org/assets/1/7/Migraine_Aura_July-August_2009.pdf ).
SOURCE: Noah Rosen, M.D., director, Headache Center, North Shore-LIJ's Cushing Neuroscience Institute, Manhasset N.Y.; Mark Green, M.D., director, Headache and Pain Management, Mount Sinai Medical Center, New York City; U.S. Food and Drug Administration, news release, Dec. 13, 2013