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New Help for Migraine Sufferers


Millions of Americans are afflicted by migraines, which typically involve intense, throbbing pain in one side of the head, along with nausea, vomiting, and sensitivity to light and sound. According to the U.S. National Institutes of Health, about 10 percent of people worldwide complain of migraines, with women affected three times more often than men.

Cefaly is a new device that has been approved by the U.S. Food and Drug Administration to be used as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.

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

Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head, accompanied by nausea or vomiting and sensitivity to light and sound. A migraine can last from four to 72 hours when left untreated. According to the National Institutes of Health, these debilitating headaches affect approximately 10 percent of people worldwide and are three times more common in women than men.

Cefaly is a small, portable, battery-powered, prescription device that resembles a plastic headband worn across the forehead and atop the ears. The user positions the device in the center of the forehead, just above the eyes, using a self-adhesive electrode. The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches. The user may feel a tingling or massaging sensation where the electrode is applied. Cefaly is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes.

The FDA reviewed the data for Cefaly through the de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

The agency evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium. 

The 67-person study showed that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device. The device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.

The patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use. The most commonly reported complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session. No serious adverse events occurred during either study.

Although the FDA categorized the Cefaly as a transcutaneous electrical nerve stimulation (TENS) unit, it is more specifically an external trigeminal nerve stimulation (eTNS) unit. The premise of the Cefaly is similar to that of other neurostimulators being tested for migraine treatment. Since the trigeminal nerve is involved in migraine, it’s theorized that stimulation of it can help with migraine prevention. It should be noted that “regular” TENS units should not be used in place of the Cefaly.  The settings to the device are not shared so trying to mimic the comfort through a modified TENS unit could exacerbate the nerve response causing more discomfort. 

As health care providers know, a lot of migraines are continued through a rebound medication effect and is counter-productive for relief. Although Cefalymay not be a fix-all, it’s a start at relieving the pain of migraines. 

Pain Centers of Iowa P.C. is excited to bring to our migraine sufferers another non-medication option to treating migraines. We have started carrying this device for the last couple of months and “people are very interested” in trialing this exciting new treatment option. For more information about migraine relief, call 563-344-1050. Pain Centers of Iowa is located at 5515 Utica Ridge Road, Suite 600 and can be found online at www.pcipain.com

Source: www.FDA.gov
Photo credit: svetikd/iStock