Cefaly, a headband intended to stop migraines, has been approved by the Food and Drug Administration. The battery-powered plastic headband is the first device made to treat migraines.
The headband sends low electrical currents to the brain and is supposed to be worn for 20 minutes a day. The currents are intended to stimulate the cranial nerves that are connected to migraine pain.
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"This device is a promising step forward in treating migraine headaches, as it addresses an important part of what we believe triggers and maintains a migraine attack," Dr. Myrna Cardiel, a clinical associate professor of neurology at New York University Langone Medical Center, told HealthDay News.
Migraines consist of intense pulsing or throbbing pains in one area of a person's head and can invoke nausea and/or vomiting as well as sensitivity to light and/or sound, according to the Food and Drug Administration.
Migraines, which can last four to 72 hours, affect about 10 percent of people globally. Migraines are three times more common among women than men.
"Cefaly provides an alternative to medication for migraine prevention," Christy Foreman, director of the FDA's Office of Device Evaluation, said in a statement. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."
CEFALY Technology manufactures the headband, which is already available in Europe, Canada, and Australia. The New York Daily News noted that the headband
can only be prescribed by a doctor to patients 18 and older.
The FDA evaluated the safety and effectiveness of the headband based during a study conducted in Belgium involving 67 people who suffer two migraines or more per month and had not taken any medications to prevent migraines for three months.
"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 FDA statement read. "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."
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