Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head accompanied by nausea and/or vomiting and sensitivity to light and sound.
A migraine can last anywhere between 4 and 72 hours when untreated. These debilitating headaches affect about 10 percent of people worldwide and are three times more common in women than in men. About third of people with migraines experience an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.
"Millions of people suffer from migraines and this new device represents a new treatment option for some patients," Foreman said in a statement.
The Cerena TMS is a prescription device used after the onset of pain associated with migraine headaches preceded by an aura. Using both hands to hold the device against the back of the head, the user presses a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain, which may stop or lessen the pain associated with migraine headaches preceded by an aura, Foreman said.
The FDA reviewed a randomized control clinical trial of 201 patients who had mostly moderate to strong migraine headaches and who had auras preceding at least 30 percent of their migraines. Of the study subjects, 113 recorded treating a migraine at least once when pain was present.
The study showed that nearly 38 percent of 113 subjects who used the Cerena TMS when they had migraine pain were pain-free 2 hours after using the device compared with about 17 percent of patients in the control group. After 24 hours, nearly 34 percent of the Cerena TMS users were pain-free compared with 10 percent in the control group.
Patients must not use the Cerena TMS device if they have metals in the head, neck, or upper body that are attracted by a magnet, or if they have an active implanted medical device such as a pacemaker or deep brain stimulator. The Cerena TMS device should not be used in patients with suspected or diagnosed epilepsy or a personal or family history of seizures, the manufacturer eNeura Therapeutics said.
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