Updated April 01, 2014.

If you suffer from migraines, you know how debilitating these serious headaches can be - with symptoms ranging from nausea, throbbing head pain, to visual disturbances and sensitivity to light and sound.  While certain prescription medications - along with avoiding your individual triggers like  food additives like MSG, stress, and lack of sleep - should reduce the number of migraines you suffer each month, a non-drug option was approved by the US Food and Drug Administration (FDA) in 2014 to help prevent migraine attacks.

 

In its statement, the FDA suggests the battery-operated device Cefaly might be beneficial for patients who can't tolerate various prescription medications designed to treat or prevent migraines.

• Read more: How to manage multiple medications safely

A different device called Cerena Transcranial Magnetic Stimulator (TMS) was approved by the FDA in 2013 to treat migraines preceded by visual, auditory or motor problems (called "aura").

What's the prevention device?  Called Cefaly, it's essentially a headband worn Wonder Woman-style just above your eyes.  It attaches to a self-adhesive electrode patch containing conductive gel that sticks to your forehead.  Once you press the power button, the Cefaly transmits a small electric current to the skin for a preset period of 20 minutes.

Though the FDA approval specifies its use for the prevention of migraine, the device has three strength settings and is marketed for both preventing and treating an ongoing attack.

The sensation has been described as a tingling or massaging on the forehead and scalp.

 

Developed in Belgium, Cefaly has been available without a prescription in Europe and Canada prior to its approval in the United States. 

How does it work?  The Cefaly headband  uses transcutaneous electrical nerve stimulation, or TENS technology, to stimulate the trigeminal nerve, which has been linked to migraines.  The trigeminal nerve is one of the largest of 12 pairs of nerves in the head, and conducts sensations throughout the face and scalp.

TENS has been widely used to treat pain ranging from arthritis to lower back pain and pain during labor and delivery, using small portable devices called TENS units which direct small impulses of electricity to the nerves around the area through the skin.

The effectiveness of TENS technology has been debated somewhat within the scientific community, with some skeptics claiming any beneficial effect results from the user's belief that it will relieve pain (the placebo effect.) 

How effective is Cefaly?   The FDA approval was based on a small study in Belgium and a satisfaction survey conducted among users of the device in Europe.

The study involved 67 subjects who typically suffered two migraine attacks per month.  They were asked to avoid pain medications for three months prior to the Cefaly trial.  The subjects who tried Cefaly reported "significantly fewer" days with migraines each month, according to the FDA - though migraines were not completely prevented, nor was the intensity of the migraines that did occur reduced.

The satisfaction survey, published in 2013 in The Journal of Headache and Pain, was conducted among more than 2,300 adults in France and Belgium who'd used Cefaly.  About 53% of respondents were satisfied with the device after using it for an average of 58 days, reporting that they'd be willing to purchase and continue using it.

Respondents who stopped using the device complained of disliking the feeling it produced, experiencing painful burning sensations on the forehead, and suffering headache after the session, according to the survey results.

When to use the headband:  On the manufacturer's website, daily use of the Cefaly (that is, one 20-minute session each day) is recommended for the prevention of migraines.  People in the throes of a migraine attack are instructed to use the device repeatedly up to 120 minutes - though using the Cefaly this way is not included in the FDA approval guidelines.

Who shouldn't use the Cefaly headband:  The device should be not be used by those under the age of 18, while driving, or by adults with recent facial or brain trauma.  The manufacturer states the device is safe for pregnant women and people with pacemakers.

Cost:  The price of Cefaly ranges from $250-$350 in Canada, with some online retailers charging the lower price.  Sets of two replacement electrodes sell for between eight and twelve dollars.  Electrodes need to be replaced every 7-10 uses as the conductive gel dries out, according to the Canadian distributor's website.

Will it work for you?  Preventing and treating migraines is a challenge for anyone who suffers from them.  Sometimes a single trigger alone will prompt a debilitating attack, other times a lack of sleep, stress and other circumstances will work in concert to bring one on.  Not all remedies work 100% of the time.  The European satisfaction survey results cited by the FDA suggest that 1 in 2 people would continue to use the Cefaly; those odds may persuade or deter you from trying it.

Availability:  The FDA's approval requires that the device be obtained with a prescription.
<sub>Sources:
Migraine. US National Institutes of Health Public Information Sheet. Accessed March 14, 2014.
http://www.nlm.nih.gov/medlineplus/ency/article/000709.htm

Bigal ME1, Liberman JN, Lipton RB. "Age-dependent prevalence and clinical features of migraine." Neurology. 2006 Jul 25;67(2):246-51.

Cooke LJ1, Rose MS, Becker WJ. "Chinook winds and migraine headache." Neurology. 2000 Jan 25;54(2):302-7.

Delphine Magis, Simona Sava, Tullia Sasso d’Elia, Roberta Baschi and Jean Schoenen. "Safety and Patients’ Satisfaction of Ttranscutaneous Supraorbital NeuroStimulation (tSNS) with the Cefaly Device in Headache Treatment: a Survey of 2,313 Headache Sufferers in the General Population." The Journal of Headache and Pain 2013, 14:95 doi:10.1186/1129-2377-14-95
http://www.thejournalofheadacheandpain.com/content/14/1/95

Trigeminal Neuralgia Fact Sheet. US National Institute of Neurological Disorders and Stroke (NINDS) Public Information Sheet. Accessed March 16, 2014.
http://www.ninds.nih.gov/disorders/trigeminal_neuralgia/detail_trigeminal_neuralgia.htm</sub>