Introducing the First FDA-approved Device 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. Sufferers will understandably anticipate and appreciate any effective prevention and treatment methods at the Headache Clinic, including medications, lifestyle changes, and the first FDA-approved device.

What It Is

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 exclusively for the use of adults and it is available only on prescription.

The Cefaly is used by wearing it across the forehead and over the ears akin to a headband, which makes it easy to use for adults of all ages. You will position the device in the center of your forehead between your eyes with a self-adhesive electrode and then wear it for 20 minutes per day.

What It Does

It must first be noted that 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 and, thus, the intense pain associated with migraines can be prevented or lessened.

You may experience a tingling or massaging sensation during the application of the mild electric current but don’t worry – it’s normal, even pleasant. Just be sure to follow the 20-minute recommendation for best results.

Experts like Dr. Myrna Cardiel of the NYU Langone Medical Center welcome the device for good reasons. The Cefaly is considered as a promising step forward in the treatment of migraines because it directly addresses one of the triggers of an attack.

While there are no serious side effects reported during the clinical studies, a few participants complained of their dislike while using the device. Others also complained of sleepiness during the session and headaches after the treatment, the latter of which runs counter to the device’s original intention.

All in all, nonetheless, the Cefaly appears to have comparable effect in migraine treatment with most oral preventive medications for migraines. Since many migraine patients complain of side effects from anti-migraine medications, the device can be a viable substitute.

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, 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.

Will you benefit from using the Cefaly? Ask your doctor about it now.

About Healthpointe:

Healthpointe is a leading multidisciplinary healthcare organization offering a full range of medical services in practice locations throughout Southern California (Los Angeles County, Orange County, San Bernardino County, and Riverside County). Healthpointe has locations situated in over 10 cities in Southern California including La Mirada by Whittier, La Habra, Norwalk, Cerritos, Buena Park, and Santa Fe Springs. As a highly regarded musculoskeletal group, we have a personal investment in the highest level of service, and we are proud of our record of excellence over the last four decades with private patients, injured workers, urgent care, personal injuries, and professional and non-professional athletes. Leading our organization is a dynamic team of healthcare professionals who continually strive to be at the forefront of medical innovation and healthcare service delivery. For more information, a complete list of services, and Healthpointe locations, visit

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