Migraine Devices

The US Food and Drug Administration (FDA) has approved a few migraine devices as an option for preventing and managing migraines.^1-4 While prescription drugs are often the first choice for treatment, these medical devices may be used with or as an alternative to drugs used to reduce migraine symptoms.

The devices currently approved for the US market include:^1-4

• Cefaly: acute and preventive treatment
• gammaCore Sapphire: acute and preventive treatment
• Nerivio: acute treatment only
• sTMS mini: acute and preventive treatment

Migraine devices generally have few side effects, especially compared with some medicines. They are effective in reducing the number of headache days and the length of migraine attacks. You do not need surgery to use these devices. All are portable, rechargeable, and battery-powered.^1-4

How do migraine devices work?

Migraine disease is linked to hyperactivity in the brain. Although each device works differently, each involves neuromodulation. Neuromodulation uses electrical currents or magnetic fields to stimulate nerves that affect brain activity. Each device is placed on a different part of the body and works on different parts of the nervous system.^1-5

Are migraine devices acute or preventive?

Some – but not all – devices are approved for both acute (or abortive) and preventive treatment. They are used differently for each purpose. To stop a migraine attack, you use a device when the pain starts. To prevent a migraine, you use the device 1 to 3 times daily, depending on the device. Talk to your doctor about the best way to use your device.

Do I need a prescription for migraine devices?

gammaCore Sapphire, Nerivio, and sTMS mini require a prescription from your doctor. Cefaly does not. Some devices must be purchased. Others are rented. Some require prescription refills. Others are limited to a certain number of uses. Insurance coverage varies.^1-4

Migraine devices: preventive and acute

Cefaly

Cefaly is approved for both acute and preventive treatment of migraine. Cefaly uses electrical energy to stimulate the trigeminal nerve. The trigeminal nerve runs from the brain to the face. This technique is called external trigeminal nerve stimulation, or eTNS.

It is worn on the forehead. Acute sessions last for 1 hour. Preventive sessions last for 20 minutes daily. You can adjust the intensity of the device. Cefaly does not require a prescription.

gammaCore Sapphire

gammaCore Sapphire is approved for acute and preventive treatment of migraine. This device is also approved for acute and add-on preventive treatment of cluster headaches. It is placed against the neck.

The device delivers mild electrical energy to the vagus nerve. The vagus nerve runs from the brain through the face to the belly. This technique is also called noninvasive vagus nerve stimulation, or nVNS. One session lasts 2 minutes. Full treatment may include several sessions. You can change the intensity level as needed. A gammaCore refill card is needed for ongoing use.⁷

sTMS mini

sTMS mini is approved for acute and preventive treatment of migraine for those ages 12 and older. It is placed at the base of the skull. The device delivers 1 pulse of magnetic energy at the push of a button. Several pulses may be needed.⁶

This technique is called transcranial magnetic stimulation or sTMS. The device is rented. The prescription is refilled by replacing the SIM card. Older models of this device include the Spring TMS and Cerena.⁶

Migraine devices: acute treatment only

Nerivio

Nerivio is approved for acute treatment of migraine with or without aura in people ages 18 and older. The device delivers weak electrical pulses. These pulses turn on pain-blocking mechanisms in the brain. This technique is called peripheral electrical stimulation, or PES.⁸

Nerivio is worn on the upper arm. You control the intensity of the treatment through your smartphone. The intensity should be strong, but not painful. Each treatment lasts 45 minutes. Nerivio lasts for 12 treatments.⁸

How well do these devices work?

The clinical trials for each device had different designs and looked at different groups of people. These differences make it hard to compare the results. The size and quality of these trials vary.^9-13

In general, studies of acute use found:^9-12

• 36 percent to 63 percent reported 50 percent less pain at 1 hour.
• 17 percent to 30 percent who use these devices for acute treatment were pain-free at 2 hours.

In some studies, they were not able to determine if some of the study endpoints were statistically significant for people treated with the device versus those in the placebo group (no treatment).^10,12

In clinical trials, people who use these devices had about 2 fewer migraine days per month.^6,14,15

Who is a good candidate for treatment with a device?

Devices may be a good option for people who cannot take migraine drugs or do not find the drugs helpful.¹⁶

Who should not be treated with a device?

It is important to read the manual for your device. Warnings and precautions vary. In general, these devices are not right for people with:

• Implantable devices such as a pacemaker or hearing aid
• Metal implants such as stents or bone plates

These devices have not been studied in children or pregnant women. They may not be safe for people with epilepsy or heart problems. Talk with your doctor about your medical history, including the prescriptions and supplements you take. Your doctor can help decide how your current migraine treatment plan will be affected and which device will be safe for you to use.^1-4

Side effects of migraine devices

Migraine devices are an important option to help patients who may be sensitive to the side effects of migraine drugs, or for those who want a drug-free approach. Each person may respond differently to specific treatments.^1-4

Each kind of device may have its own set of possible side effects. The long-term effects of these devices are unknown. Most of the symptoms end shortly after the end of each treatment session.^1-4

People in clinical trials had few side effects from using these devices. The most common side effects included:¹⁷

• Pain, irritation, or discomfort where the device was placed
• Dizziness
• Muscle spasms or twitching
• Feeling mild tingling, pricking, or pins and needles
• Headache or migraine

Are migraine devices right for you?

These migraine devices are an option to improve quality of life and reduce or eliminate migraine pain. They may be enough to prevent or treat migraine for some people. However, they are just 1 form of migraine treatment.

Because each person with migraine has unique symptoms, treatments are based on the person’s symptoms, age, and general health, and how they respond to different treatment options.^1-4

It is important for people with migraine to see a neurologist or headache specialist who is trained in the use of these devices. Specialists understand how these devices work, how they should be used, and whether a device is safe for each person’s overall health.^1-4