Originally published April 15 2014
High-tech tiara is medicine-free approach to preventing migraines
by J. D. Heyes
(NaturalNews) It might sound like something out of a science fiction movie, but a new tiara-type device has recently been approved by the Food and Drug Administration as a drug-free treatment for migraine headaches.
According to the agency, the device is called "Cefaly" and is manufactured by STX-Med in Herstal, Liege, Belgium. It is designed to be a preventive treatment for migraines and is the first transcutaneous electrical nerve stimulation (TENS) device the FDA has authorized for use to curtail 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."
Doctors characterize migraine headaches by the intense pulsing or throbbing pain in a single area of the head. They are generally accompanied by nausea and/or vomiting, as well as extreme sensitivity to light or sound, or both.
Migraines can last for a few hours or a few days -- up to three -- when they are left untreated. The National Institutes of Health says that these debilitating headaches affect some 10 percent of the world's population; they are three times more common in women than men.
As reported in an FDA press release:
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.
Most trial users would buy Cefaly
The agency said it reviewed the data on Cefaly through what is known as the de novo premarket review pathway, which is a "regulatory pathway" for medical devices that are considered generally low- to moderate-risk and are not substantially equivalent to a device that is already being legally marketed.
The FDA said it examined and evaluated the safety and effectiveness of the device based on information gleaned from a clinical study that had been conducted in Belgium involving 67 subjects who experienced more than two migraine attacks a month, and who had not taken any medicines to prevent migraines for three months before using Cefaly. The FDA also evaluated a patient satisfaction study of 2,313 device users in France and Belgium.
The 67-subject study demonstrated that those using Cefaly went significantly fewer days suffering migraines each month and used far less migraine attack medication than those who were using a placebo device. Cefaly did not, however, completely prevent migraines or reduce the intensity of those that did occur, the FDA said.
Still, more than 53 percent of patients in the study said they were satisfied with Cefaly treatment and, furthermore, said they would be willing to purchase the device for subsequent continued usage.
Of the most common complaints, users said they disliked the feeling of the device and therefore did not want to continue using it; another complaint was sleepiness during treatment sessions followed by a headache.
"No serious adverse events occurred during either study," said the FDA.
There are some other natural ways to reduce your risk of migraines as well:
-- Apply a hot or cold press to your head. It's not known exactly why this works, but some people swear by it.
-- The herb feverfew, known as Tanacetum parthenium, has been used as a folk remedy for migraines and headaches in general.
Read about more natural migraine treatments here.
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