Cefaly is an external trigeminal nerve stimulation (eTNS) device used as a preventive treatment measure for migraine. It’s approved by the Food and Drug Administration (FDA), and it’s thought to work by addressing the trigeminal nerve in the brain to help stop migraine symptoms.

The device works similar to transcutaneous electrical nerve stimulation (TENS) units, which are typically used to treat muscle and nerve pain. However, this eTNS device is made specifically to wear on the forehead.

Cefaly is available by prescription for people with chronic or acute migraine. It may be especially helpful for those who are not getting relief from other treatments. While Cefaly has been proven to be safe overall, its long-term efficacy remains unknown.

Here’s what you need to know about the Cefaly eTNS device and how it may work in your overall migraine treatment plan.

Proponents of Cefaly claim that the eTNS device is both safe and effective in the treatment of migraine. Here’s a list of pros and cons to consider based on the anecdotal and clinical research available so far:

Pros of Cefaly:

  • The device is easy to use, and it’s both wireless and portable.
  • It’s noninvasive.
  • The treatment is drug-free, which may reduce concerns associated with taking medications for migraine.
  • It can be used to prevent migraine or during acute attacks.
  • You can start with lower intensities and gradually increase them as you get used to the device.

Cons of Cefaly:

  • The electrostimulation may be uncomfortable at first.
  • Side effects may include drowsiness and sleepiness.
  • Skin irritation may develop from the sticky electrode patches.
  • You can’t drive a car or operate other heavy machinery after use.
  • It’s unknown whether the device is safe for use in pregnant people, children, or people who have pacemakers.

Cefaly is available by prescription only. If you have medical insurance, it’s important to check with your insurance ahead of time to see if they will cover the device along with additional reusable electrodes. In some cases, you may have to buy the device first and then submit a receipt for reimbursement.

The average out-of-pocket cost for the device is $299, with additional electrodes sold separately at $25 for a set of three. You’ll also need to replace the two AAA batteries once they run out of power.

Cefaly has been approved by the FDA for people over age 18 with migraine. It may also be used in cases of migraine with and without aura (visual disturbances).

While the exact causes of migraine are unknown, research suggests that neurological abnormalities in the brain could contribute. As an eTNS device, Cefaly may help by stimulating the trigeminal nerve.

The trigeminal nerve is responsible for feelings in your head and face. It’s thought that related migraines could arise from a blood vessel pressing on the nerve. As a result, you may experience migraine symptoms such as sudden sharp pains, especially on one side of the face.

A migraine treatment plan can vary, but it often consists of a combination of medications and lifestyle changes to help prevent attacks. Using Cefaly regularly may help prevent migraine, as well as provide relief during an acute migraine episode.

The FDA approved Cefaly in 2014 based on initial research that suggested the product could possibly help migraine without major side effects. They also found that regular, daily use may reduce the number of days people have migraine.

A 2018 review looking at the effectiveness of Cefaly found that regular use of the device changes pathways in the trigeminal nerve. In theory, this could result in fewer migraine symptoms.

Additionally, a 2018 randomized controlled trial found eTNS technology helped decrease acute migraine symptoms. Out of 109 study participants, none reported any serious side effects.

One long-term study published in 2019 also looked at eTNS technology in people with seizures. Researchers found a high retention rate, along with reports of better mood and sleep. No serious side effects were found.

Follow these steps for using Cefaly:

  1. First, wipe the skin on your forehead and between your eyebrows. (Your initial kit should include skin wipes for this purpose).
  2. Place the device in the middle of your forehead, with the lower edge between your eyebrows. The logo on the device should also be right side up, with the power button underneath it.
  3. Make sure the electrode patch underneath the device sticks firmly against your skin. You will need to change these out after several uses, or whenever the electrode no longer sticks.
  4. Turn on the power button when you’re ready. You can also manually adjust the intensity levels.

You can use the Cefaly device daily for up to 20 minutes at a time. While it’s primarily intended as a preventive measure for migraine, you may also use it during an attack.

For best results, Cefaly is designed for regular use to help stop symptoms before they occur.

What it feels like

When you turn on your Cefaly device, you’ll feel a tingling sensation. Too high of an intensity may be painful at first, so you’ll want to start off low and gradually progress to higher levels as you get used to the unit.

After several minutes, you may get used to the tingling sensation so it’s not as noticeable. In treating acute pain, you might even find the tingling makes you feel better.

Your initial Cefaly kit will include the following items:

  • eTNS device and two AAA batteries
  • a case for storing the device when it’s not in use
  • one electrode, which may be used up to 20 times
  • wipes to clean your skin prior to use

Cefaly is the first device of its kind approved for migraine treatment.

Also, while Cefaly uses nerve stimulation similar to TENS devices, these should not be used interchangeably. As an eTNS unit, Cefaly is designed for safe use on the forehead to help treat migraine.

A typical TENS device doesn’t have the same features, and most aren’t indicated as safe to use on the head. As a rule of thumb, it’s a good idea to check with a doctor before trying out any nerve-stimulating devices.

If you’re shopping for a device like Cefaly, it’s important to make these distinctions from widely available TENS units at drugstores. Keep in mind that Cefaly is available by prescription only.

Migraine is a complex condition that’s often difficult to treat. While medications and lifestyle changes can help, it’s still possible to experience migraine.

Cefaly may offer both preventative and immediate relief for migraine. It tends to work best when used daily. Your doctor may prescribe this device in addition to other therapies you may be using in your current treatment plan. Do not stop taking any medications unless your doctor tells you to.

It’s important to use Cefaly as directed and to report any new or worsening symptoms to your doctor right away. Do not use other over-the-counter nerve stimulating devices, as these typically are not meant for migraine treatment.