Cefaly is a device used to treat and prevent migraines. Worn on the outside of the forehead, it delivers electrical impulses to stimulate nerves thought to play a role in migraines. The device is approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute migraine and the prevention of migraine. As of 2020, the device is available without a prescription.
How Cefaly Works
The Cefaly device is a trigeminal nerve stimulator (e-TNS) powered by two AAA batteries to generate an electrical current that is then sent to electrodes worn on the skin of the forehead.
This current stimulates a branch of the trigeminal nerve. This cranial nerve controls sensation in the face and is believed to play a role in migraines. However, the current does not directly reach the entire trigeminal nerve. Instead, it reaches the supratrochlear and supraorbital branches of the ophthalmic nerve, a branch of the trigeminal nerve.
The mode of action of e-TNS is unclear. Originally, experts hypothesized that nerve stimulation would block ascending (ascending) nerve activation in the pain pathway. However, this hypothesis is not supported by the findings, and the current explanation is that the device may directly interact with the brain regions that recognize neuropathic pain—namely the limbic system and the cerebral cortex.
Knowledge about cranial nerves and their function
how to use it
Cefaly is positioned by placing the electrode in the center of the forehead and sticking it to the skin using the self-adhesive backing provided. The e-TNS is then attached to the electrodes using magnetic attachments that hold the two components together. Press the power button to start treatment.
According to its manufacturer, the Cefaly device’s amperage increases gradually over the first 14 minutes of use. If you feel the current is too strong for you, you can press a button to stabilize the intensity and stop increasing it further.
The Cefaly device has two settings: one for migraine prevention and one for use during acute migraine.
for migraine prevention
Migraine prevention relies on taking prescription medication every day. Like medications used to prevent migraines, Cefaly can be used daily.
The FDA’s approval of Cefaly as a preventive treatment is based on the results of two European trials: the PREMICE trial and the European Postmarketing Surveillance Study.
The PREMICE trial was Cefaly’s randomized controlled trial conducted by the Belgian Headache Society between 2009 and 2011.
The study included 67 participants who had had at least two migraine attacks per month prior to the study. Some participants received Cefaly, and some received sham or placebo. The treatment period for each participant lasted three months.
Here are the findings:
- By the third month, patients treated with Cefaly experienced a significant decrease in migraine and headache days.
- Participants receiving Cefaly had a 29.7% reduction in migraine days (compared to a 4.9% reduction in participants receiving the sham treatment) and a 32.3% reduction in headache days (compared with a 3.4% reduction in the placebo group) %).
- In the group receiving Cefaly, 38.2% of patients experienced at least a 50% reduction in migraine days per month.
- People using Cefaly have not reported any negative side effects.
European Postmarketing Surveillance Study
A registry was established for all persons who acquired Cefaly devices between September 2009 and June 2012, most of whom lived in France and Belgium. After using the device for 40 to 80 days, they were asked to participate in a survey that assessed satisfaction and concerns about negative side effects.
The results of this post-marketing study showed that about 53 percent of people 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.
for migraine attacks
After the device was already 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 in the treatment of acute migraine is published in the journal neuromodulation October 2017.
The study included 30 participants who had a migraine headache for at least three hours and were not taking any medication during the migraine attack. Treat with Cefaly for one hour.
Mean pain intensity was significantly reduced by 57% immediately after one hour of treatment and 52.8% one hour after nerve stimulation was completed. The percentage of patients who did not require any other medication after two hours was 100% and after 24 hours it was 65.4%.
The researchers did not report any adverse events or complaints from participants about the treatment.
That said, Cefaly has reported some side effects, although none of them are serious. The most common side effects include:
- tingling skin sensation
- Drowsiness during meetings
- headache after class
- skin irritation
The manufacturer does list contraindications you should be aware of. Cefaly cannot be used if you have:
- Implant metal or electronic devices in your head
- unexplained pain
- Pacemaker or implantable or wearable defibrillator, which may interfere with pacing, shock or death
Experts are not sure if Cefaly is safe during pregnancy, so if you use this device, be sure to tell your healthcare provider if you are pregnant or plan to become pregnant.
Cefaly appears to be as effective as other treatments for migraine, including triptans and NSAIDs. One of the potential downsides to the device is that you may have to pay out of pocket, as many health insurance plans don’t cover it.
Unlike the drug, however, Cefaly has not been reported to have any serious side effects, which can be an advantage if you experience side effects from migraine medications.
Frequently Asked Questions
What are the side effects of Cefaly?
Side effects of Cefaly may include skin tingling, drowsiness during application, headache after application, and skin irritation. It is considered very safe for most people.
Does Cefaly have insurance?
No; Cefaly is not covered by insurance in many cases. However, it may still be worth contacting your health insurance provider to ask.
Nerve stimulation device for migraine