Migraine device receives approval

The US Food and Drug Administration (FDA) has approved the marketing of a device for preventing migraine headaches. The federal agency says the device, which delivers a nerve-stimulating low electrical current, could be of benefit to patients that cannot tolerate migraine drugs.

The Cefaly device is the first transcutaneous electrical nerve stimulation device specifically authorised for use prior to the onset of pain. It is a small, battery-powered plastic headband worn across the forehead. The user attaches it with a self-adhesive electrode, just above the eyes. The device delivers a low electric current through the skin and may cause a tingling or massaging sensation. The current stimulates the trigeminal nerve, which has been associated with migraine headaches.

Test results found that compared with patients using a dummy device, those using Cefaly reported significantly fewer days per month with migraine headaches and using less medication. However, Cefaly did not completely prevent migraine attacks and did not reduce their intensity when they occurred.

Christy Foreman, director of the Office of Device Evaluation at the FDA's Centre for Devices and Radiological Health, commented: "Cefaly provides an alternative to medication for migraine prevention. This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."

The FDA reviewed a study conducted in Belgium involving 67 people of who were having at least two migraine attacks a month and who ceased taking migraine medication for the 3 months leading up to the start of the trial.

The FDA also carried out a patient satisfaction survey of 2,313 Cefaly users in France and Belgium that found 53% were satisfied with the treatment and would buy it again.