Nerve Stimulation Devices for Migraine Treatment

If you experience migraine, whether chronic or episodic, there may be a “zap” for that.

Bad wordplay aside, nerve stimulation has proved to be an effective option for some people who have this often painful neurological disease.

“The underlying theory is there are targets in the central and peripheral nervous systems that can be manipulated using electrical or magnetic pulses on nerves that are directly or indirectly involved in pain processing,” explains Matthew Robbins, MD, an associate professor of neurology at NewYork-Presbyterian and Weill Cornell Medicine in New York City.

“In most people, I don’t see nerve stimulation replacing medication altogether, but it can be used alongside prescribed drug treatment to reduce migraine episodes or pain intensity,” says Dr. Robbins. “It may also help reduce reliance on medication to address symptoms,” he adds.

Nerve stimulation, sometimes called neuromodulation, isn’t one single approach.

Although they generally work the same way, the methods vary according to which nerves are targeted in the procedure and how the stimulation is applied. These are the most commonly used approaches for migraine:

• Supraorbital stimulation targets the branch of the trigeminal nerve that brings sensation to the forehead, upper eyelid, and scalp.
• Vagus nerve stimulation (VNS) targets the vagus nerve, which extends from the brainstem to the abdomen and communicates with a variety of muscles and organs along its entire length, including the small intestine and colon.
• Occipital nerve stimulation (ONS) targets nerves on the back of the scalp.
• Remote electrical neuromodulation (REN) stimulates peripheral nerves in the arm, with the goal of blocking pain signals from reaching the brain.
• Single-pulse transcranial magnetic stimulation (sTMS) is not aimed at any particular nerve but rather at the brain more generally.

In supraorbital stimulation, or external trigeminal nerve stimulation (e-TNS) — sometimes referred to as transcutaneous electrical nerve stimulation (TENS) — your doctor recommends a specific level of microimpulses that target the upper branch of the trigeminal, or supraorbital, nerves, which research suggests are involved in migraine attacks.

These pulses are delivered using a device that you place on your head when you feel a migraine attack coming on, or during an attack to relieve pain. The device is available with a prescription or over-the-counter (no prescription required) in many pharmacies.

Once your doctor has suggested an appropriate level of stimulation for your migraine symptoms, you administer the treatment yourself at home.

Cefaly

The Cefaly external e-TNS device is designed to be worn on the forehead. It uses magnets to attach to a reusable electrode that sticks to the skin with adhesive. The device can be used once daily for 20 minutes to prevent attacks and for up to 60 minutes during a migraine attack to relieve symptoms. The user chooses a preventive or acute program when applying the device and selects the intensity of the treatment. The device turns off automatically when the program is complete.

The U.S. Food and Drug Administration (FDA) first approved the Cefaly device for the prevention of migraine attacks in 2014 on the basis of promising research data. The agency then approved the device for use in the treatment of migraine attacks in 2017.

Newer models have features like softer indicator lights and Bluetooth connectivity. They retail for about $400. Electrodes, good for multiple uses, cost about $8 each.

Relivion

Another e-TNS device, Relivion is a noninvasive headset that delivers pulses of electrical current to stimulate the occipital and trigeminal nerves.

The headset has two sensors that sit on either side of the nose (similar to the nosepieces of eyeglasses) and is intended to be put on and activated at the onset of a migraine attack. The amount and type of modulation can be controlled via an app on a paired smartphone.

The device received FDA clearance in the United States in March 2021 for at-home treatment of acute migraine in adults. It requires a doctor’s prescription.

Vagus Nerve Stimulation

GammaCore Sapphire

GammaCore Sapphire is an FDA-cleared (in 2015) handheld device that allows users to self-administer small doses of noninvasive VNS therapy to treat cluster headaches and migraine. The rechargeable and reloadable device is designed for multiyear use.

The device can be used for both acute and preventive migraine and cluster headache treatment. Users apply conductive gel to the two stimulation surfaces, then hold the device against the side of their neck, just below the jawline (either side of the neck will work), so that it can deliver small electrical pulses to the vagus nerve for two minutes at a time. The user controls the intensity of the pulses.

The suggested timing of the two-minute treatments depends on whether the user is preventing or treating migraine, or preventing or treating cluster headache.

Originally, GammaCore was approved for use in adults only. In February 2021, the FDA expanded clearance of the device to include the acute and preventive treatment of migraine in adolescents between ages 12 and 17.

GammaCore Sapphire requires a doctor’s prescription. Before use, the device must be activated with an authorization code, delivered via a radio-frequency identification card.

Without insurance, the GammaCore starter kit, preloaded with three months of therapy, costs $450. However, some healthcare insurance plans cover the device and will reimburse at least some of the charges, according to a story on Everyday Health network site Migraine Again.

Notably, ONS is different from other nerve stimulation systems in that it involves surgery, but the procedure is reversible.

One implantable device currently in development, from Salvia Bioelectronics, uses mild electrical impulses to influence nerve activity, or the pattern of electrical impulses transmitted through nerve fibers that control how your body functions. The Dutch company is working on implantable thin bioelectronic foils that conform to the shape of the head to deliver neurostimulation.

Specifically, the company’s implantable neurostimulation system (similar to a pacemaker) will be designed to use bioelectronic foil technology to disrupt the brain processes that cause migraine attacks in people for whom drug therapy has failed. In 2020, the FDA granted Salvia a breakthrough device designation for its implantable technology. The designation enables the company to have more frequent interaction with FDA regulatory experts as it prepares the device for approval.

Remote electrical neuromodulation (REN) may be particularly useful for people with migraine who are worried that using devices that apply electrical stimulation to the head area may worsen the pain associated with attacks. Uniquely, this approach is designed to stimulate the peripheral nerves in the upper arm. It is thought to reduce migraine pain by modulating a deep part of the nervous system involved in pain control. Specifically, REN activates pain control centers in the brainstem (the connection between the brain and the spinal cord), which blocks the pain signaling that occurs in migraine, according to Migraine Again.

Nerivio

The app features a migraine diary that allows you to track treatment sessions and migraine attacks. You can share the diary with your doctor to guide your migraine management.

Nerivio is available only with a doctor’s prescription at participating pharmacies and telemedicine providers. The first Nerivio device costs $49 with the Nerivio Express Savings Program, which requires that you have a pharmacy or medical insurance plan and that you give the pharmacy permission to run a benefits verification and receive any required prior authorizations. The cost of refill devices depends on the customer's insurance coverage plan.

Each Nerivio device delivers eighteen 45-minute treatments. After 18 treatments, the battery no longer works, and the device will need to be recycled.

SAVI Dual

The eNeura SAVI Dual is an FDA-approved sTMS device that is battery powered, handheld, and can be used for both the prevention and treatment of migraine attacks in adults and children age 12 and older.

The user places and holds the SAVI Dual firmly against the back of the head to cradle the base of the skull. With the push of a button, the device’s specially shaped electrical coils deliver a magnetic pulse designed to treat and prevent migraine attacks by interrupting abnormal electrical activity in the brain associated with them. The device automatically transmits a person’s treatment history to a cloud-based diary, which can be used to improve migraine management.

You need a doctor’s prescription to use the SAVI Dual. A $395 monthly prescription fee includes unlimited acute treatments and daily preventive treatments, according to Migraine Again.

Even with nerve stimulation approaches that can be self-administered, people with migraine should consult their doctors before using them, Robbins emphasizes, even if they don’t require a prescription. Your doctor can help you determine which device is right for your migraine symptoms and whether it is safe for you to use, he says.

Although the side effects of nerve stimulation differ depending on the approach used, most are mild, such as redness or irritation and muscle twitching in the area where the device is applied. A handful of people undergoing nerve stimulation have reported feeling light-headed or having a tingling sensation after treatment.

Keep in mind, also, that there are situations in which nerve stimulation can’t be used. People with epilepsy or implanted electrical devices like cardiac pacemakers probably shouldn’t use the technology, Robbins notes. It may be a good choice for people who are avoiding taking medications because they are pregnant or plan to become pregnant, are older, or are taking many other medications, he says.

The self-administered devices can be expensive and most aren’t covered by health insurance.

Despite these considerations, nerve stimulation has an important advantage over most migraine medications. “Some drugs have been linked with what’s called medication-overuse headaches — headaches associated with repeated use of the medications themselves,” Robbins notes. “There doesn’t seem to be the same issue with nerve stimulation. To be honest, it’s a treatment I’d recommend to more patients.”

• Nerve stimulation devices treat migraine by delivering electrical or magnetic pulses to specific nerves or areas of the brain.
• This technique can be used both to treat migraine symptoms and to prevent this type of headache.
• These devices may allow you to cut back on migraine medication.
• Most nerve stimulation devices require a prescription, and insurance plans often don’t pay for them.