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Introducing Cefaly; the First FDA-approved Device for Migraines

Introducing Cefaly for Migraines

Migraines are considered the worst type of headache because of the severity of the symptoms involved with each attack – intense throbbing or pulsing pain in one side of the head, nausea and vomiting, and extreme sensitivity to lights and noises, among others. Those who suffer from migraines understandably anticipate and appreciate any effective prevention and treatment methods including medications, lifestyle changes, and the first FDA-approved device.

What is Cefaly?

On March 2014, the United States Food and Drug Administration approved the first preventive device for migraines – the Cefaly, a product of Cefaly Technology, a Belgium-based corporation. While children and teenagers can also suffer from headaches, it is designed and intended for adults and it is available on a prescription-only basis.

The Cefaly is worn across the forehead and over the ears akin to a headband, making it easy to use for adults of all ages. The device is positioned in the center of the forehead with a self-adhesive electrode and worn for 20 minutes per day.

What Does Cefaly Do?

Migraine headaches are closely associated with the trigeminal nerve, the fifth cranial nerve essential for facial sensations and motor functions (e.g., chewing and biting). By applying a mild electric current to the skin and then to the underlying body tissues in the area, the branches of the trigeminal nerve are stimulated thereby easing or preventing the intense pain associated with migraines.

Cefaly users often experience a mild tingling sensation as the electric current passes through their body; this is generally regarded as a pleasant experience, and it is an entirely safe and normal process. For best results users should be sure to apply the device for a full 20 minutes.

Experts like Dr. Myrna Cardiel, of the NYU Langone Medical Center, welcome the device for good reasons. The Cefaly is considered a promising step forward in the treatment of migraines because it directly addresses one of the triggers of an attack. The adage “an ounce of prevention is worth a pound of cure” resonates strongly here, although it should be emphasized that the device is also useful in the treatment of an attack.

No serious side effects were reported during the clinical studies, although a few participants did experience sleepiness during their session and headaches post-treatment; the latter of which runs against the device’s original intention.

Nonetheless, the Cefaly appears to be comparable to most oral preventative medications in regards to migraine treatment. Since many migraine patients complain of side effects from anti-migraine medications, the device can be a viable substitute (i.e., safer yet just as effective).

According to the FDA, the approval for the device was based on the results of a Belgian clinical trial and a patient satisfaction study in Belgium and France. In the latter study, 53% of the 2,300 Cefaly users surveyed expressed satisfaction about the effect of the product and their intention to buy the device for their continued use.

Ask your doctor to see if Cefaly is right for you.

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