Migraine Devices

People with episodic migraine have options beyond medicine to control symptoms of the condition. Episodic migraine is when someone has 15 or fewer headache days per month. Neuromodulation devices offer drug-free options to people with episodic migraine. These devices use electrical pulses or magnets to stimulate the brain and nervous system.^1-3

There are 5 neuromodulation devices available for treating and preventing migraine symptoms. The devices are:^2,4-6

• GammaCore Sapphire™: approved in 2017 for those with episodic migraine who are 12 years and older
• Nerivio®: approved for episodic migraine treatment in 2019 and for prevention in 2023
• Cefaly®: approved for acute and preventative treatment in adult patients in 2014 and given over-the-counter clearance in 2020
• SAVI Dual™: approved for acute and preventative treatment of those with episodic migraine who are 12 years old and older
• Relivion® MG: approved in 2021 for acute treatment of episodic migraine

Most of these migraine devices are available with a prescription. Only the Cefaly device is available over the counter.

How do migraine devices work?

It depends on the device, but all 5 approved devices are neuromodulators. This means they all use different pathways to change, or modulate, brain activity. Some devices can stop symptoms of a migraine attack. Others can do that as well as prevent future attacks.¹

How does the GammaCore Sapphire work?

This device is a noninvasive vagus nerve stimulator. It is applied to the skin on either side of the neck. It provides electrical stimulation through 2 electrodes. Stimulating the vagus nerve reduces symptoms of episodic migraine for some people.^7,8

How does Nerivio work?

This device is a wearable armband. It is a remote electrical neuromodulator, or REN. It uses remotely activated low-energy electrical pulses to activate the body’s own pain management system. This then causes the brain to release pain-blocking messenger signals which reduce episodic migraine symptoms.^5,9

How does Cefaly work?

This device uses electrical stimulation through the skin to stimulate the external trigeminal nerve. The device is worn across the forehead and requires daily use. The “dual” part of its name refers to its ability to be programmed for episodic or chronic migraine.²

How does SAVI Dual work?

This device used to be called the eNeura® sTMS™ mini. It is applied to the back of the head where it delivers electrical stimulation as a single pulse. It is thought to alter how part of the brain called the cerebral cortex works. Different pulse patterns can be used to prevent attacks or to treat acute attacks.^2,10

How does Relivion MG work?

This device delivers electrical stimulation to 2 major head and facial nerve pathways linked to episodic migraine. The wearable device stimulates 6 branches of the occipital and trigeminal nerves. It is worn as a visor or band that fits around the entire head. Like with other neuromodulators, the stimulation is thought to trigger the brain to release signals that block or abort migraine pain.^2,11

How well do migraine devices work?

Responses to each device vary from person to person. But a study found that when REN was used every other day, it was better than a placebo in reducing:⁶

• Moderate to severe headache days
• Headache days across all severities
• Days of needing medicine for episodic migraine attacks

More than half of people in the study had half the headache days or fewer per month when using a device.⁶

Additional research has shown that REN can replace migraine drugs for some people with episodic migraine. It can also be used alongside migraine drugs for others.⁷

What are the possible side effects?

Side effects can vary depending on the specific device you are using. Migraine devices generally have very few side effects. And the side effects they do have rarely last more than a day. Users may experience:^2,4,11

• GammaCore Sapphire: facial pain, digestive (gastrointestinal) symptoms, and infections of the upper respiratory tract
• Nerivio: warmth, numbness in the arm, redness, itching, tingling, pain and muscle spasm
• Cefaly: burning or prickling, tiredness, trouble sleeping, and irritation at the electrode site
• SAVI Dual: lightheadedness, tingling, and ringing in the ears
• Relivion MG: pain or tingling, nausea, scalp numbness, skin reactions or redness at the electrode site, dizziness, fatigue, and sleepiness

These are not all the possible side effects of neuromodulation devices for migraine. Talk to your doctor about what to expect when using a migraine device. You also should call your doctor if you have any changes that concern you when using one of these devices.

What else should you know?

Neuromodulator devices may be a good choice for people with episodic migraine who:^1,9

• Have other health conditions that prevent them from taking migraine drugs
• Do not tolerate migraine drugs well
• Do not respond well to migraine drugs
• Are at risk of overusing migraine drugs

Before beginning treatment for episodic migraine, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you take. This includes over-the-counter drugs.