Nerve Stimulation Devices for Migraine Treatment

If you experiencemigraine, 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. In general, the theory behind the approach is that electrical or magnetic pulses delivered to specific nerves or to areas of the brain can prevent migraine attacks or reduce the severity of symptoms during attacks.

“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,” explainsMatthew Robbins, MD, an associate professor of neurology at 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.

Different Devices Target Different Nerves

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.

Supraorbital Stimulation

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.

这些脉冲交付使用的设备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 U.S. Food and Drug Administration (FDA) first approved theCefalyexternal e-TNS device for 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.

Both uses of the device are cleared for adults only.

The Cefaly device is designed to be worn on the forehead, with a reusable electrode contacting the skin, once daily for 20 minutes to prevent attacks. It can also be used for up to 60 minutes during a migraine attack to relieve symptoms.

Currently, the device isn’t covered by most health insurance plans. The Cefaly Dual kit, which includes the device, one electrode (good for up to 20 uses), power adapter, charging cable, and storage case, retails for $499. Three-packs of additional electrodes are available for $25.

Relivion

Another e-TNS device,Relivion, is a noninvasive headset device 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.

In a clinical trial, 76 percent of Relivion users achievedheadache reliefduring a migraine attack after only one treatment, with no serious side effects.

Previously certified only in Europe, in March 2021, the device received FDA clearance in the United States for at-home treatment of acute migraine in adults.

Vagus Nerve Stimulation

GammaCore Sapphire

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

来激活它,你的医生会为你提供a prescription-only authorization code, delivered via a radio-frequency identification (RFID) card. Users 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.

In July 2020, the FDA granted GammaCore emergency use authorization (EUA) for people withCOVID-19who are experiencing asthma-related breathing difficulties.

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

GammaCore Sapphire requires a doctor’s prescription. Without insurance, the device costs $575 per month — although some healthcare plans cover it and will reimburse at least some of the charges.

Implantable Occipital Nerve Stimulation

值得注意的是,国家统计局不同于其他神经stimulation systems in that it involves surgery, but the procedure is reversible.

One implantable device currently in development, fromSalvia 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

Currently, REN is designed to be used at the firstsign of a migraineattack.

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 from select specialty pharmacies. Each device costs $99, at full price, and delivers twelve 45-minute treatments. After 12 treatments, the battery no longer works, and the device will need to be recycled.

Single-Pulse Transcranial Magnetic Stimulation

sTMS mini

The eNeura sTMS mini is an FDA-approved sTMS device previously sold under the brand name Spring TMS. It’s a battery-powered handheld device that can be used for both the prevention and treatment of migraine attacks.

The user places and holds the sTMS mini 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.

You need a doctor’s prescription to use the sTMS mini. The primary U.S. manufacturer of sTMS technology, eNeura, declared Chapter 7 bankruptcy in 2020. As a result, it’s unclear whether the device will remain on the market, at least in the United States.

Effective, Well-Tolerated by Most, but Expensive

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 withepilepsyor 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 — costing up to $6,000 a year — 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.”