-- Scott Roberts
MONDAY, Dec. 16, 2013 (HealthDay News) -- The first device to
treat migraine pain when the headache is preceded by an
often-visual disturbance called an aura has been approved by the
U.S. Food and Drug Administration.
The Cerena Transcranial Magnetic Stimulator (TMS) is held to the
back of the head and the user presses a button to release a pulse
of magnetic energy. This stimulates the brain's occipital cortex,
which may reduce or eliminate migraine-associated pain, the FDA
said in a news release.
The device was tested in a clinical trial of 201 people with
mostly moderate-to-strong migraines. Nearly 38 percent of people
with migraine pain were pain-free two hours after use, compared
with 17 percent of people who didn't use the device, the FDA said.
The device was not evaluated among people with headaches other than
those with migraines preceded by aura, the agency said.
Among the rare side effects reported were sinusitis and
dizziness. The device shouldn't be used by people with metals in
the head, neck or upper body, or by people with an implanted
medical device such as a pacemaker or deep brain stimulator, the
The Cerena TMS is produced by eNeura Therapeutics, based in
The FDA has more about
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