New Device Could Lessen Migraine-Related Headache
The U.S. Food and Drug Administration (FDA) has approved a device for marketing that relieves migraine-related headache.
The prescription device- Cerena Transcranial Magnetic Stimulator (TMS), is for people who have migraine headaches that are preceded by an aura.
About 12 percent of the U.S. population suffers from migraines and women are three times more likely than men to suffer from this malady. Migraines are recurring attacks of moderate to severe pain that cause a throbbing or pulsating effect, usually on one side of the head. Previous research has shown that migraine could lead to brain damage.
Migraine with aura is a type of migraine that comes with warning signs or symptoms such as tingling sensation in hands and feet, flashes of light or blind spots.
"Millions of people suffer from migraines and this new device represents a new treatment option for some patients," said Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, according to a press release. Cerena TMS is manufactured by eNeura Therapeutics of Sunnyvale, Calif.
The device relieves migraine pain using magnetic energy to stimulate the occipital cortex.
FDA reviewed a clinical trial of 201 patients suffering from moderate to strong migraines. Of these, at least 113 patients sought treatment for headache during a migraine attack.
Study results showed that 38 percent of participants using the Cerena TMS were pain-free for two hours after the attack compared to 17 percent of volunteers in the control group.
The device doesn't relieve sensitivity to sounds or light. Also, patients with pacemakers, deep-brain simulators or with a history of epilepsy shouldn't use Cerena TMS, FDA said.
Side effects of using the device include sinusitis, aphasia and dizziness.