First Device to Treat Migraine With Aura Approved

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. The device is used by prescription after onset of pain associated with migraine with aura. Using both hands, the patient holds the device to the back of the head and, pressing a button, releases a pulse of magnetic energy that stimulates the occipital cortex, stopping or reducing the pain associated with this type of migraine. "The FDA reviewed the data for the Cerena TMS through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device," the FDA statement notes. They reviewed data from a randomized control clinical trial including 201 patients with mostly moderate to severe migraine headaches with auras preceding at least 30% of episodes. Of these patients, 113 recorded treating a migraine at least once when pain was present, and the analysis of these 113 patients was used to support the marketing authorization, the release said. Results showed that nearly 38% of patients using the TMS device were pain-free 2 hours after using the device vs 17% of control patients.

After 24 hours, nearly 34% of treated patients were pain-free vs 10% of the control group. However, treatment was not associated with relief of other associated symptoms of migraine, including sensitivity to light or sound and nausea, the FDA adds. The device is for use in patients 18 years of age or older, and the study did not evaluate performance of the device in other types of headaches. The device should not be used in patients who have metals in the head, neck, or upper body; who have an implanted medical device such as a deep brain stimulator or pacemaker; or those who have suspected or diagnosed epilepsy or a personal or family history of seizures, the FDA statement said.

"The recommended daily usage of the device is not to exceed 1 treatment in 24 hours," it concludes. 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 FDA said. Adverse events reported with treatment were rare in both device and control groups, the FDA release said, but included single reports of sinusitis, aphasia, and vertigo. "Dizziness may be associated with the use of the device," the agency adds. The Cerena TMS is produced by eNeura Therapeutics, based in Sunnyvale, California.