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FDA Approves Migraine Headband

March 12, 2014
Image Credit: Thinkstock.com

Brett Smith for redOrbit.com – Your Universe Online

In a statement released on Tuesday, the Food and Drug Administration announced the approval of the first-ever medical device made to prevent migraines.

Called Cefaly, the device is shaped like a tiara and delivers a “tingling” electric current to the wearer’s forehead. According to a report published in the journal Neurology last month, Cefaly decreased chronic migraine onset by two per month on average, and 38 percent of users had a minimum 50 percent decrease in their frequency of migraine attacks. The gadget was not proven to lessen the harshness of episodes reported in the study.

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

Migraine headaches are described as strong pulsing or pounding pain in one spot on the head. They are often coupled with queasiness and sensitivity to sound and light. A migraine may last from 4 to 72 hours when not treated. According to the National Institutes of Health, these incapacitating headaches affect around 10 percent of people around the world and are three times more frequent in women than men.

The FDA said it examined the safety and efficiency of the device based on the study published in Neurology, which involved 67 individuals who experienced greater than two migraine headache episodes a month and who had not used any drugs to reduce migraines for three months ahead of using Cefaly. The FDA also conducted a patient satisfaction study of more than 2,300 Cefaly users in France and Belgium that found a slightly over 53 percent patient-approval of the Cefaly treatment.

The device is designed to be worn for no more than 20 minutes per day. In contrast to migraine medications, Cefaly has no known side effects and might be combined with other drugs. The device is already on sale in Canada where it retails for around $250.

“New therapies are needed in migraine, and further studies of neurostimulation using innovative study designs are warranted to explore the optimum way to create an acceptable evidence base for widespread use of this potentially valuable treatment,” Dr. Eishi Asano, associate professor of pediatrics and neurology at Wayne State University in Detroit, wrote to CNN.

A new study being presented at the American Academy of Neurology‘s 66th Annual Meeting in Philadelphia from April 26 to May 3 offers more evidence that stress leads to more headaches.

To reach their conclusion, the study researchers surveyed nearly 5,200 people between the ages of 21 and 71 on their stress levels and headaches four times a year for two years. Participants were asked to say how many headaches they had per month and rated their stress level on a scale of zero to 100.

The study considered four different kinds of headaches: tension-type headaches, migraines, migraine combined with tension-type headache and headaches that could not be classified. The team found that for each type of headache, there was an increase in stress associated with an increase in the number of headaches per month. For those who had a migraine and tension headache, the number of headache days per month went up by 4.3 percent. The researchers said the findings were adjusted to help account for factors that may affect the number of headaches, like drinking, smoking and use of headache drugs.


Source: Brett Smith for redOrbit.com - Your Universe Online



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