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 US Food and
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
Nearly 38% of people with migraine
pain were pain-free two hours after use, compared with 17% 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 their head, neck or upper body,
or by people with an implanted medical device such as a pacemaker or deep brain
stimulator, the FDA said.
The Cerena TMS is produced by eNeura Therapeutics, based in Sunnyvale,
The FDA has more about this approval.