The United States Food and Drug Administration (FDA) has given its first approval for the production, distribution and marketing of the first ever device that can help prevent migraine. The device which looks like a headband can deliver nerve stimulating low electrical current that reduces pain during a bout of migraine and may bring relief to patients who cannot tolerate any migraine drug available in the market.
Celafy is a small and battery operated plastic headband that can be worn across the forehead. The patient can attach it through a self-adhesive electrode to be placed above the eyes. Now, the device can send low electric current signals through the skin. Patients may feel light tingling sensation that signals that the current is stimulating the trigeminal nerve. This nerve is linked to the occurrence of migraine headaches.
The FDA told the press, "This is also the first transcutaneous electrical nerve stimulation device specifically authorized for use prior to the onset of any migraine pain."
Celafy was manufactured by STX-Med in Herstal, Liege, Belgium and available on prescription for patients who are ages 18 years old and older. It is recommended to be used only once a day for about 20 minutes per session.
Christy Foreman, the director of the Office of Device Evaluation of FDA Center for Devices and Radiological Health said in an interview, ""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 government regulatory agency has reviewed and studied a research conducted in Belgium where it involved 67 people who are having two migraine attacks and bouts per month and who are not taking any medications for the last three months.
After the study, the results showed that compared to those using a control device or dummy device, those who were using the Celafy reported that there were significantly fewer days in a month when they had migraine attacks. They were also using lesser medications. However, Celafy did not completely prevent migraines but there were just fewer bouts of migraine. Also, it did not reduce the intensity of pains.
The FDA also conducted a patient satisfaction survey where they analysed answers from 2,313 patients in France and Belgium. Apparently, the results showed that 53% of users would purchase the device for personal use.
Also, there were no adverse effects reported but the most common complaints incurred were the tingling sensation when using the device and feeling sleepy during treatment. Some also complained of having slight headaches after using it.
According to the data from the National Institues of Health, migraine headaches affect 10% of the worldwide population. It is more common in women than in men. Migraine headaches have manifestations of severe and debilitating pain which can last from 4 hours up to 72 hours. It can be accompanied with vomiting, nausea and sensitivity to light and sound.