4 FDA-Cleared Devices That Can Treat Your Migraines

Millions of people across the U.S. experience migraines. Over 15% of U.S. adults report having had a migraine or bad headache in the last 3 months. For many people, migraines impact their daily lives, causing them to miss work or school, as well as needing time to recover. 

There are many different types of migraines and treatment approaches. People are often provided acute treatments, preventative treatments, or both. Acute treatments are fast-acting and help treat migraines when they happen. Preventative treatments help lower the number of migraines a person experiences.

One issue with migraine medications is that they can have side effects. Some can cause sleepiness or rebound headaches (when using medication too often can cause headaches). However, other options are now available that use technology to treat or prevent migraines without medications.
Here, we’ll review 4 new migraine devices and how they work.

1. Cefaly for migraine treatment

Cefaly is a device that you apply to your forehead to treat or prevent migraines. It’s FDA-cleared for adults over 18 years old. It provides mild electrical stimulation to a certain nerve that can cause migraines.

Side effects are uncommon, affecting less than 1% of Cefaly users. You may feel sleepy while using the device, so don’t use Cefaly while driving. You may also experience redness or skin irritation where the device was applied.

People have also reported that Cefaly can cause a headache after a preventative treatment. Contact your healthcare provider if bothersome side effects happen while using the device.

Discuss Cefaly with your healthcare provider if you:

• Are over age 65

• Are pregnant or trying to become pregnant

• Have heart conditions

• Experienced a recent head injury

• Have a history of seizures

• Haven’t been officially diagnosed with a migraine condition

• A sudden, severe headache that's different than usual

These are only some of Cefaly’s warnings. It’s always best to check with your healthcare provider before using Cefaly.

2. Nerivio for migraine treatment

Nerivio is a digital therapeutic device that’s FDA-cleared to treat acute migraines in people over 12 years old. It’s not designed to prevent migraines. Nerivio works by providing electrical pulses to the upper arm. The device is controlled by an app on a smartphone. 

During your migraine treatment, you can adjust the electrical pulses through the app. You can adjust the stimulation, making it more or less intense. Each device is good for 12 treatments, and then must be discarded. Nerivio appears to be most effective when used within 1 hour of your migraine starting. 

You may feel tingling, warmth, or slight numbness in your arm during a Nerivio treatment. But this should go away shortly after your treatment ends. If your treatment is painful, you should lower the intensity. If you experience muscle spasms or numbness of the hand, you may need to reposition the device.

Nerivio shouldn’t be used if you:

• Have heart failure or severe heart problems

• Have a history of strokes or seizures

• Have a pacemaker, implanted hearing aid, or another electrical device implanted in your body

Nerivio wasn’t studied in pregnant women. Please discuss Nerivio with your healthcare provider if you’re pregnant or trying to become pregnant.

3. Relivion MG for migraine treatment

The Relivion MG system is a headband device that’s FDA-cleared to treat migraines in adults over 18 years old. It also isn’t designed to prevent migraines. Relivion MG wraps around your head and delivers electrical pulses to nerves that can cause migraines.

The device is best used when connected to the Relivion smartphone app. The app collects and tracks information about your symptoms and treatments. This can be shared with your healthcare provider to help them personalize your Relivion treatments.

Scalp numbness, skin irritation, and sleepiness during treatment are possible side effects. If you notice any excessive or painful side effects, tell your healthcare provider. They may adjust your treatment.

You shouldn’t use Relivion MG if you:

• Have metal plates or implants in your head

• Had a brain or head injury within the last 3 months

• Have open cuts on your forehead or the back or your head

• Have a pacemaker, implanted defibrillator, or an electrical device implanted in your head

As with the above devices, discuss Relivion MG with your healthcare provider if you are pregnant or trying to become pregnant.

4. gammaCore for migraine treatment

gammaCore is a handheld device that’s FDA-cleared to treat or prevent migraines in people over the age of 12. gammaCore provides gentle electrical stimulation to a nerve in your neck that can cause migraines. The device is held to the side of your neck during treatments. 

How often and when you should use these treatments depends on the type of migraine you’re experiencing. The directions are also different when used for migraine prevention. It’s best to ask your healthcare provider how often to use your device.

You shouldn’t use gammaCore if you:

• Have a pacemaker, implanted hearing aid, or another electrical device implanted in your body

• Have a metal plate or screw implanted in your neck

• Have wet skin or open cuts on your neck

If you’re pregnant or trying to become pregnant, speak with your healthcare provider before using gammaCore.

How can you pick the right consumer medical device for your migraine treatment?

Knowing what type of migraines you have can help you decide. The devices are FDA-cleared for different migraine types, and they’re used in different ways. It’s also important to know if you’ll be using a device to prevent migraines or treat them.

This information will help your healthcare provider recommend the best device for you. In doing so, they'll take into account medications you’ve tried, how severe your migraines are, and if you have other medical conditions.

Migraine treatment devices aren’t right for everyone. It’s important to discuss it with your provider, even if the device is available over the counter (OTC).

Can you use consumer medical devices for migraine treatment instead of medication?

Yes. These devices can be used with or without medications. However, you should continue taking your medication unless your healthcare provider tells you to stop. Stopping medication on your own could cause your symptoms to worsen.

How much do Cefaly, Nerivio, Relivion MG, and gammaCore, cost?

The cost varies between devices. But they can be expensive. You should compare the cost of your current migraine treatments to the device you’re interested in. Cost may be the biggest factor in helping you decide if a migraine device is right for you. 

Here’s some information on the cost of these devices and how you might be able to save on them:

• Cefaly is available OTC. It can be bought from their website for $379. The electrodes come separately, and a pack of three costs about $25. There are payment plans available to help lower the upfront cost of the device.

• Nerivio is a prescription-only device. They offer a patient savings program that can lower the cost to $10 for your first Nerivio device. As mentioned above, each device provides 12 treatments.

• gammaCore is a prescription-only device. They offer a telehealth program on their website, which provides a 3 month device for $450. They offer a copay assistance program for people with commercial insurance. It may take up to $100 a month off your copay.

• Relivion MG is a prescription-only device. It’s relatively new, having been FDA-cleared in early 2021. Its retail cost hasn’t been announced yet.

Does health insurance cover Cefaly, Relivion, gammaCore, or Nerivio?

At this time, Cefaly and Relivion MG aren’t covered by insurance. However, Cefaly can be paid for using a health savings account (HSA) or flexible spending account (FSA). Information regarding Relivion MG may change once they release pricing information.

Nerivio is covered by some insurance plans, including the Department of Veterans Affairs (VA). It’s best to contact your insurance provider to see if they cover Nerivio.

gammaCore is covered by some insurance plans. gammaCore’s manufacturer works with a specialty pharmacy to help check for insurance coverage. Their gammaCARE program works with people to offer them financial help.

Are other consumer medical devices for migraine treatment being developed?

There’s ongoing research looking for new migraine treatments that don’t rely on medications. It’s likely many will use some form of nerve stimulation like those discussed above. But how they work and where they’d be applied may be different. This may include new wearable devices or even ones that are implanted under your skin.

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Written by:

Timothy Aungst, PharmD

Timothy Aungst, PharmD, has worked in pharmacy practice for the past decade with different roles and responsibilities. He has served as an associate professor of pharmacy practice for almost a decade, a clinical pharmacist in outpatient cardiology management, and now in home healthcare.

Edited by:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

Reviewed by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

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