The US Food and Drug Administration has given its first approval for the marketing of a device for preventing migraine headaches. The federal agency says the device, which comes in the form of a headband that delivers a nerve-stimulating low electrical current, may bring relief to patients who cannot tolerate current migraine drugs.
“This is also the first transcutaneous electrical nerve stimulation device specifically authorized for use prior to the onset of pain,” they told the press.
The Cefaly device is a small, battery-powered plastic headband that is 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.
The device, which is manufactured by STX-Med in Herstal, Liege, Belgium, and available on prescription for patients aged 18 and over, should only be used once a day for 20 minutes, says the Food and Drug Administration (FDA).
According to the National Institutes of Health, migraine headaches affect about 10% of people worldwide and are more common in women than men. The debilitating pain, which can last from 4 up to 72 hours, is felt as intense throbbing in one part of the head and is often accompanied by nausea, vomiting and sensitivity to light and sound.
Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, says:
“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 results showed 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.
The FDA also reviewed 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 for further use.
No serious adverse effects were reported by users in either study. The most common complaints that arose in the user survey included not liking the sensation of the treatment, not wanting to continue using it, feeling sleepy during treatment and having a headache afterwards.
In December 2013, the FDA approved the first medical device for the treatment of migraine headaches preceded with aura. The Cerena Transcranial Magnetic Stimulator, which is also available on prescription only, is used after the pain of migraine preceded with aura has started.