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4 Approved Migraine Devices To Know About

Posted on July 9, 2024

The U.S. Food and Drug Administration (FDA) has cleared four different devices for treating migraine symptoms. Some members of MyMigraineTeam have reported positive experiences when using these options consistently. “I’ve used my devices for a while, and I’m now seeing a noticeable improvement after four months,” shared one member. “I can even skip it sometimes, and it’s not an issue. Before, I would have been hit really hard with migraines.”

If you’re interested in learning more about nonmedication treatment options for migraines, here’s what you should know about each of the available FDA-cleared migraine devices.

1. Cefaly External Trigeminal Nerve Stimulators

Cefaly’s line of external trigeminal nerve stimulators (E-TNSes) — the Cefaly Connected and the Cefaly Enhanced — work by exciting the supraorbital nerves, including the trigeminal nerve, which has a significant effect on migraine headaches. Usage entails placing adhesive electrodes on the forehead and connecting them to the Cefaly migraine device.

The Cefaly devices have a relaxing effect that aims to reduce migraine attacks with regular use. To prevent migraines, the manufacturer recommends using the devices for 20 minutes per day. During an acute migraine attack, you may need to use the device longer, for up to one hour.

One MyMigraineTeam member noticed a benefit from the machine. “I use the Cefaly device daily for the 20-minute treatment, and luckily, my migraine pattern has dropped from several really bad migraines which would last for a week (maybe 21-23 migraine days) monthly to one mild-moderate migraine monthly,” they explained.

Another member of MyMigraineTeam shared their experience with a Cefaly device. “It works really well! It's expensive but worth every penny,” they said. “One drawback is that you have to use it on your forehead. You have to wash your forehead with soap and water, and dry it thoroughly. There can’t be oil on your skin or the electrode patch won’t stick. You have to look straight ahead while the Cefaly is working. You can’t look down or move around. If you do, the Cefaly will fall off. It’s boring for sure.”

Results take time, so it’s important to be patient when deciding whether a new device like one of the Cefaly E-TNSes is effective for you. Users are advised to expect a significant reduction in migraines after about three months of consistent use. The Cefaly devices have been shown to cause minimal side effects, including forehead numbness, in comparison to medications commonly used for migraine headaches.

The Cefaly devices don’t require a prescription. The listed price for the Bluetooth-enabled Cefaly Connected device is $424 and works with the company’s CeCe Migraine Management app, designed for tracking migraine symptoms and triggers. The Cefaly Enhanced is listed at $389. There are also monthly costs of up to $37 for periodically replacing the electrodes.

2. GammaCore Sapphire Noninvasive Vagal Nerve Stimulator

The GammaCore Sapphire is a noninvasive vagal nerve stimulator (nVNS). The FDA cleared this device to treat episodic cluster headaches. Using light electrical stimulation, the Sapphire GammaCore targets the vagus nerve, which is associated with these episodes. Stimulating the vagus nerve blocks the pain signals to the brain. You can also use it daily to help prevent migraine attacks.

To use the GammaCore, follow three basic steps. First, find the pulse on either side of your neck. You can feel around for it using your index and middle finger. Next, take off the cap and put a pea-sized dollop of the gel that came with your device on both stimulation surfaces. Finally, turn on the GammaCore and place it over the treatment area. Turn up the intensity until you feel a gentle muscle contraction on the side of your mouth (usually somewhere between levels 15 to 25).

As with any neurostimulation device, GammaCore requires regular use to be effective. Some MyMigraineTeam members have struggled with this aspect of treatment. “I’ve kinda given up on the GammaCore,” said one member. “I just couldn’t work it into my life well.”

Once you have obtained the prescription from your neurologist, you can try GammaCore. Setting a reminder to use it as recommended can help you build the habit into your day. The most recently published monthly cost for GammaCore Sapphire is $598, but check with your provider about the current cost. Adverse effects in research studies included dizziness, musculoskeletal disorders, and metallic taste, but these were overall insignificant.

3. Savi Dual Single-Pulse Transcranial Magnetic Stimulator

SaviI Dual is a brand-name single-pulse transcranial magnetic stimulator (sTMS) made by eNeura that can offer quick relief for migraine symptoms. Unlike other devices that rely on electrical currents, sTMSes use magnetic pulses to interrupt brain activity. It’s pain-free and well tolerated by most people, though some people report temporary involuntary eye blinking, facial muscle twitching, minor headaches, and mild pain at the stimulation site.

The magnetic pulse is meant to disrupt migraines by working with natural electrical currents in the brain. This low-risk method is quick and easy to use. You’ll place the device on the back of your head and press the button. After a short time, typically under a minute, the pulse is discharged, and you should start to feel relief. Most people do a few pulses twice per day to prevent migraine attacks. During migraine attacks, users may go up to 17 pulses per day. Your physician will prescribe the right number of pulses for you. According to the manufacturer, using the device for three months can have preventive benefits.

The company also offers an app called Savi Smart Diary, which automatically stores your daily treatment usage. Health experts often recommend that people living with migraine keep headache diaries to identify triggers and improve treatment.

You’ll need a prescription for the device. The cost is based on a monthly subscription fee that may or may not be covered by insurance, depending on your plan. However, rental options are available if you don’t want to invest in your own device. As a first-time user, you may also be able to find some discounts. Work with your neurologist to find ways to defray the cost.

4. Nerivio Migra Remote Electrical Neuromodulator

The Nerivio Migra is a remote electrical neuromodulator (REN) device. It’s the most recently FDA-cleared device on the list, and it’s indicated for treating migraine headaches in adults and adolescents ages 12 and up. Unlike the above devices that connect to your head or neck, Nerivio is an armband. It sends signals to the brainstem through the upper arm, helping to block pain signals associated with migraine attacks.

Nerivio is remote-controlled through a smartphone app. This app also allows you to adjust the settings and includes a migraine diary where you can track your symptoms. It’s meant to treat migraine attacks as they’re happening, with results expected within 25 minutes of use.

Side effects are minimal, but some people develop discoloration, numbness, or muscle spasms on their arm after wearing the band. It can also cause a warm, tingling feeling in the area. People who shouldn’t use this device include those with:

  • Cardiac or cerebrovascular disease
  • Congestive heart failure
  • Epilepsy that isn’t well controlled
  • Implanted medical or metallic devices

Your insurance plan may cover the cost of Nerivio. If it doesn’t, you can call the Nerivio Cares Support team for more information.

As more neuromodulation devices for migraine become available, people with the condition have more treatment options beyond relying on migraine medications. Ask your doctor for medical advice to help you get closer to enjoying a more pain-free life or at least reduce the number of migraines you have each year.

Talk With Others Who Understand

MyMigraineTeam is the social network for people with migraine and their loved ones. On MyMigraineTeam, more than 82,000 members come together to ask questions, give advice, and share their stories with others who understand life with migraine.

Have you tried any medical devices for migraine prevention or to treat sudden migraine pain? If so, what stimulation devices worked best for you? Share your experience in the comments below, or start a conversation by posting on your Activities page.

    Marie Dorsey, Pharm.D., BCPS, AAHIVP is currently a clinical pharmacist at Bridgewell Medical, specializing in medication therapy management and holds a certification as an HIV pharmacist through the American Academy of HIV Medicine. Learn more about her here.
    Anastasia Climan, RDN, CDN is a dietitian with over 10 years of experience in public health and medical writing. Learn more about her here.

    A MyMigraineTeam Member

    It's VERY frustrating that Migraine treatments are SO EXPENSIVE! Just seeing what these things cost, is almost enough to give me a Migraine!

    October 24
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