FDA Approves First Device To Relieve Migraine Pain

Last week, the Cerena Transcranial Magenetic Stimulator (TMS) became the first medical device approved by the US Food and Drug Administration (FDA) for the treatment of migraines preceded by aura in adults. The device, which is placed against the back of the head, releases a plus of magnetic energy to stimulate the occipital cortex in the brain.

The Cerena device is manufactured by eNeura Therapeutics in California. In a randomized controlled study of 201 patients, 38% of participants using the Cerena device were pain-free after two hours compared to 17% in the control group. After a full 24 hours, 34% of Cerena users remained pain-free compared to 10% of those in the control group. Study results did not show that the device relieved other common migraine symptoms such as sensitivity to light or sound, and nausea.

Reported adverse events in clinical studies were rare for both groups. These included single reports of sinusitis, aphasia, and vertigo. Dizziness may also be associated with use of the device.

The device is approved for use by prescription and the FDA recommends that daily use should not exceed one treatment in 24 hours. Individuals with metals in the head, neck, or upper body that are attracted by a magnet should not use the device. People with pacemakers, deep brain stimulators or other implanted devices, personal or family history of seizures, suspected or diagnosed epilepsy also should not use the Cerena device.

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