Migraine Devices

People with episodic migraine (EM) headache 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 EM. These devices use electrical pulses or magnets to stimulate the brain and nervous system.^1-3

There are 6 neuromodulation devices available for treating and preventing migraine symptoms. The devices are:^2,4-12

• GammaCore Sapphire®: approved in 2017 for those with EM who are 12 years and older. This device also has an indication for the treatment of cluster headache.
• Nerivio®: approved for EM treatment in 2019 and for prevention in 2023
• Cefaly Dual®: 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 EM who are 12 years old and older
• Relivion®: approved in 2021 for acute treatment of EM
• HeadaTerm: approved for the prevention of EM in people 18 and older.

Most of these migraine devices are available with a prescription. Only the Cefaly Dual 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

Examples

GammaCore Sapphire

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 EM for some people.^7,8

Nerivio

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 EM symptoms.^5,9

Cefaly Dual

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 both acute migraine treatment and prevention of migraine.²

Savi Dual

This device used to be called the sTMS mini. It is applied to the back of the head where it delivers single low-frequency electromagnetic fields that pass painlessly through bone and tissue. 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

Relivion

This device delivers electrical stimulation to 2 major head and facial nerve pathways linked to EM. 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

HeadaTerm

The HeadaTerm 2 is a forehead-worn medical device that uses non-invasive electrical stimulation to prevent and treat primary headaches, including migraine, tension headaches, and cluster headaches. It is clinically proven, safe, and effective.¹²

How well do these 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 EM 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 EM. 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 Dual: burning or prickling, tiredness, trouble sleeping, and irritation at the electrode site
• Savi Dual: lightheadedness, tingling, and ringing in the ears
• Relivion: 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.

Other things to know

Neuromodulator devices may be a good choice for people with EM 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 EM, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you take. This includes over-the-counter drugs.