With more than 100,000 devices currently in use, Cefaly is a prescription-only, FDA approved medical device that uses transcutaneous supraorbital nerve stimulation (tSNS) to help users reduce the number of migraines they experience.
According to the product’s website, most migraines originate from the trigeminal nerve, which exits the eye socket just underneath the skin of the forehead. As such, Cefaly is claimed to generate “precise micro-impulses in order to stimulate the nerve endings of the trigeminal nerve,” ultimately producing a sedative effect. And with regular use, this sedative effect can reduce the number of migraine attacks.
With this in mind, Cefaly is claimed to work over 6 steps:
- Use soap and water to cleanse the skin on your forehead.
- While looking in the mirror, place the electrode in the correct position.
- Place the Cefaly device on your forehead and lower into position. You should feel it engage with the pin on the electrode.
- Press the start button, which will beep once the session begins.
- Adjust the intensity and tingling to a level that’s comfortable.
- After your 20-minute session has ended, detach from the pin and remove your Cefaly device.
Cefaly’s manufacturer claims that, among regular users, the device has an 81% satisfaction rating, with 77% experiencing a decrease in migraines and a 75% decrease in the use of related medications. Despite this, Cefaly is claimed to be gentle and “exceptionally safe.”
Whether your migraines are moderate or severe, and whether you experience them once per month or daily, you just want them to stop. But does Cefaly provide a legitimate method that can help you accomplish this? Consider the following:
What is Transcutaneous Supraorbital Nerve Stimulation (tSNS)?
It sure is a mouthful, right? As it turns out, this phrase was invented by Cefaly’s manufacturer, so let’s break it down word-by-word:
- Transcutaneous: “Passing, entering, or made by penetration through the skin.”
- Supraorbital: “The region immediately above the eye sockets, where in humans the eyebrows are located.”
- Nerve Stimulation: “The use of electric current produced by a device to stimulate the nerves for therapeutic purposes.”
In essence, although it sounds really science-y, tSNS is simply stimulating the trigeminal nerve using electrical currents applied to the skin of the forehead.
Is There Clinical Evidence Showing Cefaly Works?
Overall, three studies are listed on the Cefaly website:
A 2013 study published in The Journal of Headache and Pain that found, “After a testing period of 58.2 days on average, 46.6% of the 2,313 [patients] were not satisfied and returned the device, but the compliance check showed that they used it only for 48.6% of the recommended time. The remaining 54.4% of subjects were satisfied with the tSNS treatment and willing to purchase the device.”
Another 2013 study showing that approximately 50% of patients achieved some kind of relief from migraines using the Cefaly device for 20 minutes per day for 3 months, and a 2011 study showing that Cefaly might help induce a sedative effect (sleepiness). However, it was noted “Additional studies are needed to determine the duration of this effect, the underlying mechanisms and the possible relation with the stimulation parameters. Meanwhile, this effect opens interesting perspectives for the treatment of hyperarousal states and, possibly, insomnia.”
What Does “FDA Approved” Mean?
According to the FDA, “approved” means that a premarket approval (PMA) application has been submitted to FDA, and that the device has been shown to be safe and effective. However, for a low to moderate-risk device such as Cefaly, this might only entail that it is “substantially equivalent to an already legally marketed device of the same type.”
Cefaly Side Effects
According to The Journal of Headache and Pain study noted above, common Cefaly side effects included pain/intolerance, arousal changes (sleepiness/fatigue/insomnia), and headache. With this said, it was reported that only 4.3% of patients experienced any of these, and they were always mild.
According to a disclaimer on the Cefaly website though:
The sensation produced by Cefaly is strange and unusual, but most people get used to it quickly after a few sessions. However some people are more sensitive and may find the sensation produced by Cefaly painful. If this is the case for you, simply press the button during the session when the sensation becomes slightly uncomfortable to limit its intensity. Only 1.25% of patients cannot stand the sensation produced by Cefaly and therefore are unable to carry out the treatment correctly.
Migraine Sufferers Talk About Cefaly
Migraine.com hosted an in-depth Cefaly review, where the author noted that it feels like “someone is pushing the heel of their hand hard into my forehead,” although they frequently found that the device was too painful to use, even in the lowest setting. In fact, they even noted, “The dozen real-life migraineurs I know of who have tried it describe the sensation as either bearably uncomfortable or too painful to use.”
Despite the manufacturer’s claims, the author also noted that they were unable to do anything other than lie down during their treatment sessions, as even the slightest movement would disengage Cefaly from the electrode, and they would have to start all over again.
Ultimately, they concluded, “Cefaly is unlikely to be the slam-dunk treatment we’d all love to have, but it could be a powerful tool in your migraine toolbox. Trying it is the only way to find out if you can stand the sensation and if it will be effective for you,” as long as it’s within your budget.
Out of 50 customer reviews on Costco.ca, Cefaly had an average rating of about 4.5 stars, with 86% of customers claiming they would recommend it to a friend. There, common compliments referenced improved migraine frequency/severity and decreased use of medications.
On the other hand, common complaints referenced failure to work (one user even claimed it made their headaches worse), and uncomfortable sensations during treatment (e.g. intense pressure, “pins and needles,” etc.).
Similarly, Cefaly had a 4.6-star rating on Amazon, with many of the same compliments and complaints noted above.
From a company perspective, Cefaly Technology is based out of Belgium, although their US operations are based out of Darien, CT. In either instance though, the company is not listed with the Better Business Bureau, although they appear to have been in business since 2008.
Cefaly Pricing & Refund Policy
Cefaly is only available through the manufacturer (prescription required) and is priced at $349.
With your order, you’ll also need to purchase a set of 3 electrodes for $25. According to the manufacturer, as long as you clean your forehead before each session, each electrode can be used up to 20 times.
Important note: As of this writing, Cefaly was not covered by medical insurance.
All Cefaly devices come with a 60-day refund policy and a 2-year warranty against defects in workmanship. In order to request a refund or process a warranty claim, you’ll need to contact customer service at (203) 309-5670.
Will Cefaly Help Reduce Your Migraine Headaches?
Chopping to the point: Like any other medical treatment (whether for migraines or any other condition), what works for you may not work for someone else, and vice-versa.
As such, even though it appears that the majority of migraine sufferers appeared to have experienced some sort of relief using Cefaly, this doesn’t necessarily mean you’ll experience the same. However, all things being equal, it appears that you’re much more likely (more than twice) to achieve positive results if you use Cefaly regularly and as recommended.
With all of this said, if you suffer from migraine headaches, you’ll almost certainly go to the ends of the Earth in order to make them stop. As such, Cefaly might represent a legitimate option to help you get there.
However, Cefaly isn’t cheap and isn’t currently covered by insurance, so you’ll definitely want to speak with your physician before making the plunge.