Neuromodulation Devices for Migraine Relief: How They Work, Benefits, and More

Some of the advances in migraine treatment aren’t medications. They’re neuromodulation devices that stimulate nerves from the outside of your body to disrupt migraine attacks inside your body. If medications are complicated for you or haven’t given you the relief you hoped for, you might want to try one of these high-tech treatments. 

How Do Neuromodulation Devices Work?

Neuromodulation devices (also called neuromodulators or nerve stimulation devices) all rely on the same basic science to relieve or prevent migraine symptoms. They apply electrical or magnetic impulses to the outside of the body to interfere with the migraine process moving along the nervous system and reduce the intensity of an attack or stop it altogether.

Jessica Ailani, MD, professor of neurology at Georgetown University in Washington, D.C., and director of the MedStar Georgetown Headache Center, talked about devices in her interview with the 2023 Migraine World Summit. “These devices show not only promise but also good evidence that they can reduce migraine attacks, that they can treat attacks when they're happening, that they really change the way the brain is perceiving pain. It's really exciting.”

Do Neuromodulation Devices Work for Migraine?

There is good clinical evidence that neuromodulators are effective at relieving migraine attacks; some are effective at migraine prevention, too. Although no one treatment works for everyone, these devices have become welcome tools in many people’s migraine toolkits. Deena Kuruvilla, MD, FAHS, a board-certified neurologist and director of the Westport Headache Institute in Connecticut, told the 2022 Migraine World Summit about the value of neuromodulation devices to her patients.

“I hear this from my patients every day — every person that we treat with chronic migraine may require different modalities of treatments, including pharmaceutical preventive treatment, devices, vitamins — the perfect marriage of treatments to help reduce their overall migraine-day burden,” said Dr. Kuruvilla. “And so, I have seen in my clinical practice that incorporating devices with mainstream prescription treatments can be helpful for people with chronic migraine in a preventive fashion, but also in an as-needed fashion.”

The devices approved in the United States are all external — you wear them or hold them up to different parts of the body. Although there have been attempts to use surgically implanted neuromodulators for migraine prevention, there isn’t enough good evidence to support their effectiveness to justify the risks. Not only do they carry the risks of any kind of invasive surgery, but the devices also can move or break inside your body.

Types of Neuromodulation Devices Available

There are five neuromodulation devices approved in the United States for treating migraine: Cefaly, gammaCore, Nerivio, Relivion, and SAVI Dual sTMS. Here’s what we know about each one.

Cefaly for Migraine

The Cefaly neuromodulation device is approved in the United States for the acute treatment of migraine with and without aura in adults and for the prevention of episodic migraine in adults. Cefaly uses electrical impulses to stimulate the supraorbital nerve above the eyebrows, a branch of the trigeminal nerve and a common location for migraine pain. It is available without a prescription, the only one of the devices on the market available over the counter.

Users wear the Cefaly device by attaching a reusable electrode patch to their forehead and clicking the device onto the electrode’s magnets. The device can then deliver a 60-minute acute treatment or a 20-minute preventive treatment. Users can adjust the intensity of the treatment to find the level that delivers a strong vibration or buzzing sensation without causing pain. Cefaly also comes with a smartphone app that users can synchronize with their devices to record usage data and results.

How Much Does Cefaly Cost?

According to the manufacturer’s website, the latest version of the device, Cefaly Connected, is $424 as of May 2023. An older version of the device that does not connect to your phone via Bluetooth is available for $389. The company offers financing options to pay for the device over a period of months.

There is also an ongoing cost of electrodes. You must purchase electrodes for about $10 each (a pack of three electrodes costs $25). Electrodes need to be replaced when they no longer adhere to the skin.

Do You Need a Prescription for Cefaly?

No, you don’t. In the United States, the Cefaly device is available without a prescription.

Does Cefaly Work? What the Clinical Evidence Says

Prevention: In a randomized, double-blind, sham-controlled 2013 study for migraine prevention in Belgium, 38 percent of participants who tried an earlier version of Cefaly (which used a headband) had at least a 50 percent reduction in the number of headache days versus 30 percent in the sham group.

Acute treatment: The ACME study, published in the journal Cephalalgia in 2018, tested Cefaly for acute treatment of migraine. In this study, 59 percent of participants who used Cefaly had a reduction in pain intensity after one hour, and the relief lasted up to 24 hours.

Nearly 8 out of 10 users experienced pain relief, and 32 percent of Cefaly users reported pain freedom after using the device.

gammaCore for Migraine and Cluster Headache

The gammaCore is a vagus nerve stimulation device approved in the United States for acute and preventive migraine treatment in patients 12 and older. It is also approved for acute and preventive treatment of cluster headache in adults. The gammaCore device is available by prescription only.

The vagus nerve runs from the head into the chest and abdomen, affecting pain, respiration, heart function and circulation, digestion, the fight-or-flight response, and more. Stimulating it may regulate pain signals and other processes throughout the body.

Users hold the device against the vagus nerve branches, located on either side of the neck, and administer electrical pulses in recommended patterns. The gammaCore device is approved for use in migraine, cluster headache, and other headache disorders and has emergency clearance or ongoing research into conditions like post-COVID asthma, PTSD, and gastroparesis.

How Much Does gammaCore Cost?

The cost of gammaCore is not available on the manufacturer’s website. A customer service representative told Migraine Again that most insurance plans will not cover the device, and Medicare and Medicaid certainly will not cover it. Financial assistance is not currently available.

Those who receive insurance benefits through CVS Caremark or Express Scripts have the best chance of getting coverage for gammaCore. A specialty pharmacy can conduct a benefit review to see if your insurance plan will cover the device and to inform you of out-of-pocket costs. The pharmacy can facilitate prior authorizations and appeals to try to get the device covered through insurance. To initiate a benefit review, prescribers should complete a “Commerical Patient Enrollment Form” and fax it to the number at the top of the form.

If you cannot get insurance coverage for the device, you can submit a prescription directly to electroCore through its gC Direct Program, which is a cash-pay program. Through this program, the cash price is $450 for the first three months and $600 for every subsequent three-month refill. To access gammaCore through this program, prescribers should complete a “gammaCore Direct Prescription Form” and fax it to the number at the top of the form.

Do You Need a Prescription for gammaCore?

Yes, a prescription for gammaCore is required to access the device.

Does gammaCore Work for Migraine? What the Clinical Evidence Says

Acute treatment: A randomized, double-blind, sham-controlled trial tested gammaCore as an acute treatment for migraine. The results of the PRESTO trial for gammaCore showed that the actual treatment was more effective than the sham.

Further, 12.7 percent of patients who used gammaCore were pain-free after 30 minutes, compared with 4.2 percent who used the sham device. Twenty-one percent of gammaCore users were pain-free after 60 minutes, compared with 10 percent in the sham group, and 41 percent had mild or no pain after 120 minutes versus 27.6 percent in the sham group.

Prevention: The 2022 PREMIUM II study confirmed that gammaCore was safe and effective for migraine prevention. Participants who tried gammaCore experienced an average reduction of 3.12 migraine days a month, compared with an average reduction of 2.29 migraine days for participants who received sham treatment.

Nerivio for Migraine

Nerivio is a remote electronic neuromodulation device approved in the United States for acute and preventive treatment of migraine in patients 12 and older. It comes with a smartphone app that controls the device and tracks usage. The Nerivio app also offers users optional relaxation therapy and education modules. The device is available by prescription only.

Theranica, the company that developed Nerivio, says the device works by stimulating upper-arm peripheral nerves to induce conditioned pain modulation. That response can trigger a chain of neurological responses that inhibits the migraine process, reducing or stopping the pain.

Users must first open the Nerivio smartphone app, set up an account, and connect it to the device by Bluetooth technology. To use the device, they peel the reusable shield away from the electrode on the back of the device (and save it so they can replace it onto the device when finished), stick it on the upper arm, fasten it with the enclosed armband, and start the 45-minute cycle. You can use Nerivio on an every-other-day schedule for migraine prevention and for acute treatment as needed.

How Much Does Nerivio Cost?

The cost of Nerivio varies depending on insurance coverage and eligibility for its savings program. According to the manufacturer’s website, the cost for the first device for new users is $49, plus a $45 physician visit fee. However, the list price for the device is $599.

The cost may be covered by insurance. The company offers a Patient Savings Program that can lower the cost of the first device to $10. The device must be replaced after a set number of treatments. Depending on insurance, some people can get refill devices for $0 or up to $99. Talk with your provider and insurance company to determine the cost for you.

Do You Need a Prescription for Nerivio?

Yes, a prescription for Nerivio is required to access the device.

Does Nerivio Work? What the Clinical Evidence Says

Six different trials have tested Nerivio’s safety and effectiveness for acute and preventive treatment in adults and adolescents. The highlights:

Acute treatment: A pivotal open-label study tested the Nerivio device for acute treatment in participants with chronic migraine. Nearly 60 percent of device users had pain relief at two hours and 20 percent had pain freedom at two hours; 40 to 50 percent of users reported freedom from nausea/vomiting, photophobia, and phonophobia at the two-hour mark. Nearly 75 percent reported sustained relief at 24 hours and 57 percent said they experienced relief in at least half of their Nerivio treatments.

Adolescents: An open-label study with participants ages 12 to 17 demonstrated that the Nerivio device was safe and effective for adolescent patients. Nearly 72 percent of device users were pain-free at two hours and half of those (almost 36 percent of total) also eliminated symptoms like nausea, photophobia, and phonophobia. Ninety percent of device users had sustained pain freedom or pain relief at the 24-hour mark and nearly 7 out of 10 had improved functional ability at two hours and 24 hours after use.

Prevention: A 2023 randomized controlled trial tested Nerivio for migraine prevention. Participants with episodic migraine who used the actual device had a mean reduction in headache days of 3.2 days, compared with 1.0 days in sham device users. Participants with chronic migraine had a mean reduction in headache days of 4.7 days, compared with 1.6 days in sham device users. Just over half of all device users had at least a 50 percent reduction in moderate/severe headache days versus 35.7 percent in the sham device group.

Relivion MG for Migraine

The Relivion MG device is approved in the United States for the acute treatment of migraine in adults. It delivers electrical stimulation to the trigeminal and occipital nerves in the head. Relivion MG is available by prescription only.

The Relivion headband is designed to stimulate the trigeminal nerves through the forehead above the eyebrows and the occipital nerves in the back of the head. Both nerve branches are involved in the migraine process and Relivion is the only neuromodulator currently available that stimulates both at the same time.

The adjustable headband comes with pads to insert for contact with the skin and a smartphone app to control the device and save information about usage.

How Much Does Relivion MG Cost?

According to the manufacturer’s website, the initial fee for a 90-day Relivion Therapy Program is $200. After that program concludes, it costs $75 per month to continue treatment.

Do You Need a Prescription for Relivion MG?

Yes, a prescription for Relivion MG is required to access the device.

Does Relivion MG Work? What the Clinical Evidence Says

Two randomized, sham-controlled clinical studies tested the Relivion device for acute migraine treatment:

In the first study, 53 percent of participants with the active Relivion treatment had reduced pain intensity at one hour versus 10 percent of participants with the sham device. At two hours, 41.7 percent of Relivion users reported pain freedom, compared with 20 percent for sham users.

Overall two-thirds of people who used the device reported headache relief at two hours compared with one-third of users of the sham device.

In the second study, 6 out of 10 participants using the active device reported pain relief at two hours after starting a treatment cycle, compared to 37 percent using the sham device.

Nearly half of the active device users reported pain freedom at two hours without requiring rescue medication, compared with 12 percent of sham device users. At the 24-hour mark, 36 percent of active Relivion device users reported being free of pain and most bothersome symptoms versus 8 percent of sham device users.

SAVI Dual TMS for Migraine

The SAVI Dual sTMS transcranial magnetic stimulation device is approved for acute and preventive use in the United States for people with migraine 12 years and older. It is the only device on the list to use magnetic stimulation instead of electrical stimulation. SAVI Dual sTMS is available by prescription only and includes a smartphone app that keeps a migraine diary for you based on your usage.

Users hold the device to the occipital area of the back of the head and press a button to administer a single transcranial magnetic pulse. Users may administer several pulses per day in patterns prescribed by their healthcare providers for acute or preventive care. Some users notice a buzzing sensation.

How Much Does SAVI Dual Cost?

The SAVI Dual device costs $395 per month for an unlimited number of acute treatment and daily preventive treatments.

Do You Need a Prescription for SAVI Dual?

Yes, a prescription for SAVI Dual is required to access the device.

Does SAVI Dual sTMS Work? What the Clinical Evidence Says

Preventive and acute treatment: In the ESPOUSE open observational study, nearly half of those participants who finished the trial had a greater than 50 percent reduction in the number of headache days when they used the SAVI sTMS device. Significant numbers of participants also required acute medication on fewer days than their baselines and showed improved quality of life.

Adolescents: Another open trial studied the use of the SAVI sTMS device in adolescent patients with migraine. Participants ages 12 to 17 reported significant improvements after using the device for 16 weeks:

• Mean number of headache days went from 13.3 to 8.8
• Mean number of moderate/severe pain days went from 7.0 to 4.2
• Mean number of days requiring acute medication went from 5.3 to 3
• Mean scores on PedMIDAS questionnaires (the children and adolescent version of the MIDAS test experts use to assess patient levels of disability from migraine) dropped from 673 to 27, representing a big improvement in overall quality of life.

How Are Neuromodulation Devices Tested? Who Pays for tests?

Clinical studies for devices like neuromodulators don’t always work the way that randomized, double-blind clinical trials (RCTs) do for medications. With certain medical devices, participants can tell if they’re getting a “sham” treatment from a modified device instead of a genuine treatment from the real device. Some placebo devices may emit electrical or magnetic impulses that have an unexpected effect and invalidate the results.

Some device trials are "open" trials, meaning that the participants know they're using a real device. Researchers then use statistical and scientific techniques to determine whether the test device delivers results better than the placebo effect they would expect. These techniques aren't appropriate for all kinds of tests, but with so much validated information about the placebo rates with medications for migraine, these techniques help researchers reach reasonable conclusions about device results.

Other devices were tested in “sham-controlled” trials where “sham” devices work like placebos in RCTs for medications. In these trials, researchers were able to alter the sham devices so that they delivered sham sensations without therapeutic benefits.

Clinical trials for devices like neuromodulators for migraine are typically funded by the manufacturers, but regardless of who pays for the tests, clinical trials must meet certain scientific and ethical standards to be accepted as evidence for regulatory approval.

What Are the Benefits of Neuromodulation Devices?

Neuromodulation devices have several big benefits for certain patients:

Minimal Side Effects

Nerve stimulation devices don’t have the same side effects and medication interaction risks that pharmaceutical treatments do — a big plus for patients who can’t use many medications, like people for whom existing medications are contraindicated or who find medication side effects intolerable. Most trial and study participants said the few side effects they experienced on these devices were mild and tolerable.

Absence of Rebound Effects

Neuromodulation devices appear to be free of rebound effects. That’s excellent news for people at risk of developing medication overuse headache (MOH). People with migraine whose attacks are increasing in frequency and severity may start using acute treatments more frequently — but increased use of acute treatments can backfire, feeding a painful, difficult-to-treat escalation of migraine. For people experiencing increases in attack frequency and severity, neuromodulation may provide acute relief and, in some cases, increased prevention success without amplifying the risk of MOH.

Adolescent Patients

Three of the devices have U.S. Food and Drug Administration (FDA) clearance for patients as young as 12 years old. Many migraine medications are not approved for or safe for patients under 18. Adolescent patients appear to have even better results from neuromodulators than adults, without the side effects and risks of medication or MOH.

What Are the Risks of Neuromodulation Devices?

Neuromodulators may be safer options for many people with migraine, but there are some people who should not try them:

• None of the devices has been evaluated for use in pregnant or breastfeeding patients.
• People who have metallic implants in the head or neck (Note: Some device makers specifically mention that dental implants are acceptable, but you should confirm your eligibility with your healthcare provider before you try any of these devices.)
• People who have implanted electrical devices, such as pacemakers or implanted hearing aids, or, in the case of the SAVI Dual sTMS, any medical implant that might be susceptible to magnetic impulses (if you can’t get an MRI, this means you)
• People who have epilepsy or seizure disorders, or who are at increased risk for seizures
• People who have severe cardiac disease, who have had stroke, or who are at increased risk for stroke
• Some devices carry warnings about use near oxygen tanks or critical medical devices that might be disrupted by magnetic or electrical fields in proximity.

Neuromodulators should not be used when the part of the body it makes contact with has inflamed, wounded, or irritated skin

Other risks and side effects of neuromodulators include:

• Risk of seizure, although the risk is very low for people who do not have any history of seizure activity
• Risk of side effects, including dizziness, nausea/vomiting, headache, and unpleasant tingling sensations
• Some people have localized skin reactions to device electrodes.

Adolescent patients who used the SAVI Dual sTMS device in clinical trials said that the device was difficult to carry around school and required a usage schedule that wasn’t always practical in a school setting. Researchers adjusted the usage schedule in the trial to make the device easier for student-patients to use.

Other devices may be easier or more difficult for individual users depending on their own circumstances, such as whether they can sit quietly for the duration of a treatment cycle or how easily they can carry and use the device outside the home.

Will Insurance Cover Migraine Devices?

Unfortunately, most insurers in the United States still don’t cover neuromodulation devices for migraine.

“The medical device situation is complicated and very frustrating,” said Shoshana Lipson, executive director of the patient advocacy group Migraine Meanderings. Nerivio is covered by specific limited commercial insurance plans in some portions of the United States, but most insurers have not covered any neuromodulators at all. Lipson said that some patients have been able to get devices covered as a TENS (transcutaneous electrical nerve stimulation) unit under the “durable medical equipment” (DME) aspect of their insurance plans, but you and your healthcare provider should talk about that possibility before you approach your insurance plan.

Some manufacturers offer a support/savings/coupon program, but those programs may not be available to people who use government-supplied health insurance like Medicare or Medicaid.

The surprising bright spot for neuromodulator coverage is for U.S. military personnel. The U.S. Department of Veterans Affairs  cover gammaCore, Cefaly, and Nerivio, thanks to the work of several migraine advocacy groups raising awareness of the pervasiveness of headache disorders in military personnel.

The Coalition for Headache and Migraine Patients (CHAMP) publishes updated information about accessing insurance coverage for migraine treatments, including devices, and financial assistance programs for migraine treatments. If you need guidance for talking to your insurer or information about financial support programs, visit the CHAMP site as well as the manufacturers' websites.

Main Points

• Neuromodulation devices have proved safe and effective for many people with migraine, although some people with certain medical implants or preexisting conditions and risks should not try them. They use electrical or magnetic stimulation applied externally to different parts of the body to disrupt the migraine process. Users wear the devices or hold them up against certain parts of the body to administer treatments.
• Several devices have clearance for use in the United States for use in the acute treatment of migraine in adults. Some also have clearance for use in migraine prevention. Three have clearance for use in adolescent patients (ages 12 to 17), who don't have as many approved options for migraine treatment as adults, and evidence suggests that adolescent patients may have even better results with neuromodulators than adults.
• The devices can be expensive to purchase or rent and are rarely covered by health insurance. Recurring costs can include regular recharging or replacement, refills for electrodes, and other accessories. Manufacturers have financial assistance programs, but U.S. patients who use Medicare or Medicaid are not eligible for financial support or "coupon" programs. U.S. military personnel using health insurance provided through the Department of Defense or the Veterans Administration may have an easier time getting coverage for neuromodulators, several of which are approved in their systems.
• Neuromodulation devices may not entirely replace medication for people with migraine disease, but they may be especially useful for people who can’t take many migraine medications or don’t get much relief from existing medications. These devices may be helpful add-ons for people with chronic migraine or for people with episodic migraine whose attack frequency is increasing.
• These devices have few side effects and are safe to use with medications, but they are not safe for all patients. People who have implanted metal devices, implanted electrical devices, or are at increased risk for seizures should not try neuromodulation devices.
• The Cefaly device is available without a prescription, but the other devices are available only with a prescription from your healthcare provider. Whether you choose over-the-counter or prescription, talk to your healthcare provider about your health history, risks, and potential benefits before you try a neuromodulation device.