Migraine? This 'tiara' can prevent it
11:11 AM
By HealthDay - March 11, 2014
The U.S. Food and Drug Administration on Tuesday approved the first device aimed at preventing migraines.
The
device, called Cefaly, is a headband-like device that runs on a battery
and sits across the forehead and over the ears, the FDA said in a
statement.
"The user positions the device in the center of the
forehead, just above the eyes, using a self-adhesive electrode," the
agency explained. "The device applies an electric current to the skin
and underlying body tissues to stimulate branches of the trigeminal
nerve, which has been associated with migraine headaches."
Cefaly
is made by Belgium-based Cefaly Technology and is available by
prescription only. The device is only indicated for use by adults and
should only be used for 20 minutes per day, the FDA said. The agency
also noted that "the user may feel a tingling or massaging sensation
where the electrode is applied."
One migraine expert welcomed news of the device's approval.
"This
device is a promising step forward in treating migraine headaches, as
it addresses an important part of what we believe triggers and maintains
a migraine attack," said Dr. Myrna Cardiel, a clinical associate
professor of neurology at NYU Langone Medical Center and NYU School of
Medicine in New York City.
She added that the rate of positive
response to the Cefaly device "appear to be comparable to what we see
with most oral migraine preventive medications."
Millions of
Americans are afflicted by migraines, which typically involve intense,
throbbing pain in one side of the head, along with nausea, vomiting and a
sensitivity to light and sound. According to the U.S. National
Institutes of Health, about 10 percent of people worldwide complain of
migraines, with women affected three times more often than men.
The
FDA said Cefaly's approval was based on the results of a clinical trial
in Belgium involving 67 people who had more than two migraine attacks
per month and who had avoided medications in the three months prior to
trying the device. Compared to people using an inactive placebo device,
people who used Cefaly had "significantly fewer" days spent battling
migraines compared to nonusers. They also had less need for migraine
medications, the FDA said.
Approval was also based on a "patient
satisfaction study" of more than 2,300 Cefaly users in Belgium and
France. That study found that 53 percent of people who tried the device
said they were satisfied with it and would buy one for continued use.
The
cost of the device in the United States is not known yet, but it sells
for about $300 in Canada, according to the company's Canadian website.
Some
of the study participants did say they disliked the feeling of using
the device. Others complained of sleepiness during the treatment
session, and headache after the treatment, the FDA said. No serious
side effects were reported.
Dr. Mark Green is the director of the
Center for Headache and Pain Medicine at the Icahn School of Medicine at
Mount Sinai in New York City. He said that Cefaly shows "some promise"
in treating migraines.
However, "since the device is not currently
available, there is little practical experience, and we anticipate its
release," he added.
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