-- E.J. Mundell
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
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.
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