Using Cefaly for Migraine Prevention and Treatment

Cefaly is a device used for the treatment and prevention of migraines. It is worn externally on the forehead, and it delivers electrical impulses that stimulate nerves that are believed to play a role in migraines. This device is approved by the U.S. Food and Drug Administration (FDA) and you need a doctor's prescription to obtain it.

Cefaly comes in three models: Cefaly Acute (for acute migraine attack treatment), Cefaly Prevent (for migraine prevention), and Cefaly Dual (for both purposes).

The Cefaly device is a trigeminal nerve stimulator (e-TNS) powered by two AAA batteries to generate an electrical current that then is sent to an electrode that is worn across the skin of the forehead.

This current stimulates a branch of the trigeminal nerve. This cranial nerve controls the sensation of the face and it is believed to play a role in migraines. The electrical current doesn't directly reach the whole trigeminal nerve, however. Rather, it reaches the supratrochlear and supraorbital branches of the ophthalmic nerve, a branch of the trigeminal nerve.

The mode of action by which e-TNS works is unclear. Initially, experts postulated that neurostimulation blocks ascending (upgoing) nerve activation in the pain pathway. However, this hypothesis was not supported by the research findings, and the current explanation is that the device may interact directly with the regions of the brain that recognize neuropathic pain—that is, the limbic system and the cerebral cortex.

Cefaly is positioned by centering the electrode on the forehead and sticking it to the skin with the provided self-adhesive backing. The e-TNS is then connected to the electrode using a magnetic attachment that holds the two components together. The power button is pressed to begin a treatment session.

According to its manufacturers, the electrical current of the Cefaly device gradually increases in intensity during the first 14 minutes of use. If you feel that the current is becoming too intense for you, you can press a button to stabilize the intensity and halt any further increase in intensity.

Migraine prevention relies on taking prescription medication on a daily basis. Like medications used for migraine prevention, Cefaly is used every day.

The FDA approval for Cefaly as a prophylactic treatment was based on the results of two European trials: the PREMICE Trial and the European Post-Marketing Surveillance Study.

The PREMICE Trial was a randomized controlled trial of Cefaly, which was conducted between 2009 and 2011 by the Belgian Headache Society. This study included 67 participants who had at least two migraine attacks each month prior to the study. Some participants received Cefaly treatment and some received a sham, or placebo, treatment. The treatment period for each participant lasted for three months.

Here are the results of the study:

• Those receiving Cefaly treatment experienced a significant decline in migraine and headache days by the third month of treatment.
• Participants who received Cefaly treatment experienced 29.7 percent fewer migraine days (compared to 4.9 percent who received sham treatment) and 32.3 percent fewer headache days (compared to 3.4 perfect in the placebo group).
• In the group receiving Cefaly treatment, 38.2 percent of patients experienced at least a 50-percent reduction in monthly migraine days.
• There were no negative side effects reported among those using Cefaly.

A registry was established for all of the people who obtained the Cefaly device between September 2009 and June 2012, most of whom lived in France and Belgium. After having used the device for between 40 and 80 days, they were asked to participate in a survey assessing satisfaction and concerns about negative side effects.

The results of this post-marketing study showed that about 53 percent of those who used the device were satisfied with the treatment and wanted to continue using it, while about 4 percent were dissatisfied with the device. None of the complaints involved serious adverse effects.

After the device had already been approved for migraine prevention, the FDA also approved Cefaly for the treatment of acute migraine attacks.

An open-label trial examining the safety and efficacy of Cefaly for the treatment of an acute migraine was published in the journal Neuromodulation in October 2017. The study included 30 participants who were experiencing migraines for at least three hours and had not taken any medication during the migraine attack. Treatment with Cefaly was given for one hour.

The average pain intensity was significantly reduced by 57 percent immediately after the one-hour treatment and by 52.8 percent an hour after the neurostimulation was completed. The percentage of patients who did not need to take any other medication was 100 percent after two hours and 65.4 percent after 24 hours.

The researchers did not report any adverse events or participant complaints about the treatment.

That said, there have been some side effects reported with Cefaly, although none of them are serious. The most common side effects include:

• A tingling skin sensation
• Sleepiness during the session
• A headache after the session
• Irritation of the skin

The manufacturer does list contraindications that you should be aware of. You cannot use Cefaly if you have:

• An implanted metallic or electronic device in your head
• Pain of unknown origin
• A cardiac pacemaker or implanted or wearable defibrillator, which may cause interference with pacing, electric shock, or death

Experts aren't sure if Cefaly is safe during pregnancy, so if you use this device, be sure to tell your doctor if you are pregnant or planning on becoming pregnant.

It appears that Cefaly works as well as other treatments for migraine headaches, including triptans and NSAIDs. One of the potential disadvantages of the device is that you may have to pay for it out-of-pocket, as it is not covered by many health insurance plans.

Unlike medications, however, Cefaly has not been reported to have any serious adverse effects, which can be an advantage if you experience side effects from your migraine medications.