Cefaly® is an FDA-approved external trigeminal nerve stimulation (e-TNS) device for the prevention and/or treatment of migraine attacks. The original Cefaly device to receive approval was indicated for the prevention of episodic migraine. There are now multiple devices available: Cefaly Acute, Cefaly Prevent, and the Cefaly dual.1-3

The original Cefaly Prevent device is for daily use in the prevention of migraine. It is a technology indicated for people with migraine age 18 and older who experience frequent migraine attacks. The newer Cefaly Acute is for use during a migraine with or without aura.1 The Cefaly Dual combines the technology used in both machines and can be used for preventive and acute treatment. The Cefaly devices are an option to improve quality of life and reduce or eliminate migraine pain.2

Cefaly is made by Cefaly Technology, a company based in Belgium. It specializes in using electronics for medical applications. It uses external cranial stimulation which is a non-invasive, drug-free approach to managing migraine.1 These wearable devices are rechargeable and battery-powered for the prevention or acute treatment of migraine. Cefaly requires a prescription.

How does Cefaly work?

Cefaly sends electrical impulses to the trigeminal nerve area of the brain that can cause migraine pain. The trigeminal nerve extends to the eye socket, up to and underneath the skin of the forehead.2

The unit contains the electronics, a battery, magnets, and an electrode. When worn, the electrode should be in contact with the forehead. The treatment starts with the push of one button and the device turns off automatically after treatment.1 The Cefaly technology uses specific impulse levels to address the different phases of migraine and can be adjusted manually.1-2

Cefaly Acute uses high-frequency stimulation in a single long session. It produces a sedative or calming effect on the nervous system that relieves head pain.2

Cefaly Prevent uses low-frequency stimulation in short daily sessions. With regular use, it can improve the migraine-triggering threshold, which results in fewer migraine attacks.2

Cefaly use involves 6 steps

  1. Cleanse the skin on the forehead
  2. Position the electrode on the forehead
  3. Place the Cefaly with its magnets against the electrode across the forehead
  4. Start the treatment by selecting the program if you are using the Dual and pressing start, or just pressing start if it is the Acute or the Prevent
  5. Adjust the intensity as needed
  6. Remove the device at the end of the session after it automatically shuts off

What are some of the possible side effects of Cefaly?

Neurostimulation devices are an important option to help people who may be sensitive to the side-effects of migraine drugs, or for those who want a drug-free approach. According to the manufacturer, Cefaly can stop a migraine without medication and with “next-to-no side effects."1-2

The most common side effects of Cefaly include:

  • Not liking the feeling of Cefaly on the forehead
  • Irritation of the skin or allergic reaction on the forehead
  • Headache or fatigue during or after a session

Cefaly should not be used by people with:

  • Implanted metal or medical devices in the head
  • Cardiac pacemaker or implanted or wearable defibrillator
  • Suffer from pain of unknown origin

Talk to your doctor about using Cefaly if:

  • You are under 18 or over 65 years of age
  • Are pregnant or may become pregnant
  • Have heart problems
  • Had a recent head injury or ever had a seizure

This is not a complete list of side effects.1-2 Talk to your doctor about whether Cefaly is right for you.

Things to know about Cefaly

Eight out of 10 people using Cefaly report significant pain relief.2 Study results reported reduced migraine pain by 65 percent of users. Thirty-two percent were pain-free within an hour.1

Prescription drug treatment has been the standard of care for both the prevention and treatment of migraine. Cefaly offers both a preventive measure and another treatment option for people with migraine.1-3

Continuous use of Cefaly requires periodically replacing electrodes. Each unit comes with directions, and cleaning and storage instructions.2

For more details, read additional information about Cefaly.

Reviewed June 2021