Nerve Stimulation Medical Devices for Migraine Headache

Non-Drug Options for Preventing Attacks and Relieving Pain

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Medications aren't the only options for managing migraines. There are a growing number of medical devices that affect neural activity in the brain in order to relieve pain and, in some cases, prevent headaches from occurring. Among the advantages of such neuromodulation devices over drugs such as non-steroidal anti-inflammatory medications and triptans is they do not present a risk of headache "chronification"—or headache worsening.

Three of these devices have been approved by the U.S. Food and Drug Administration (FDA) and already are in use: e-TNS, sTMS, and the gammaCore non-invasive vagus nerve stimulator. Several others are being studied, according to the American Migraine Foundation.

If you are interested in a non-pharmaceutical approach to migraine management or are simply seeking an alternative to your current treatment approach, talk with your doctor to see if this option may be right for you.

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External Trigeminal Nerve Stimulation Device (e-TNS)

Marketed as the Cefaly, the e-TNS device is based on a technology called transcutaneous electrical nerve stimulation (TENS), which is often used in physical therapy settings for relief of back and other pain. In March 2014, Cefaly was the first neurostimulator approved by the FDA for preventing migraines. In December 2017, it was approved to stop acute headaches from progressing.

What it is: e-TNS is a diamond-shaped device about the size of the palm of your hand that attaches magnetically to a self-adhesive electrode positioned in the center of the forehead. Currently, there are three versions: Cefaly Prevent, Cefaly Acute, and Cefaly Dual.

How it works: The device generates a current of electricity that stimulates nerves in the forehead, particularly the trigeminal nerve that plays a key role in migraine headaches.

Effectiveness: In the study that led the FDA to approve Cefaly for migraine prevention, a significant number of migraine patients who wore the device daily for a designated amount of time had at least a 50 percent decrease in headache days.

The FDA approved Cefaly for stopping migraine attacks as they occur based on a clinical trial titled the Acute Treatment of Migraine with External Trigeminal Nerve Stimulation (ACME). In this study, there was a 65 percent reduction in the pain intensity of migraines, and 32 percent of participants were pain-free within an hour of treatment.

Side effects and contraindications: In studies, only about 4 percent of people who used Cefaly had any side effects, all of which were mild and reversible. The most common was being unable to tolerate the feeling of the device on the forehead. Others include fatigue during and after treatment sessions, headache after one session, and skin irritation. The most severe side effect reported: allergic skin reaction to the electrode.

Cefaly is approved for most adults 18 and over, but according to the FDA its safety for children, pregnant women, and people with pacemakers hasn't been established.

Spring Transcranial Magnetic Stimulator (sTMS)

The FDA gave the sTMS device the green light in December 2013. It was originally approved to treat migraine with aura, but also is prescribed for migraine without aura.

What it is: The SpringTMS is a rectangular device that's curved to cradle the back of the head while being held with both hands. It contains a magnet that is turned on for a split-second pulse. Called the sTMS mini, the device is manufactured by a company called eNeura that rents the device in three-month increments by prescription only.

How it works: The primary cause of a visual aura that precedes a migraine headache is a wave of depressed nerve activity in the brain that sweeps across the cortex called a cortical spreading depression (CSD). The Spring sTMS device uses magnetic energy to disrupt this wave when used within one hour of the onset of an aura.

Effectiveness: In the study that prompted the FDA to approve the Spring TMS, people who suffered from migraine with aura were divided into two groups: One set of subjects was given an sTMS device and the other group was given a nonfunctional device that looked exactly like the real thing. Both groups were told to use their device for up the three migraine attacks during a three-month period. None of the subjects knew which device they were using.

Two hours after treatment, the people using the sTMS device experienced significantly more relief than those who used the sham device. They also were more likely to be pain-free 24 hours and 48 hours after treatment. What's more, participants who had moderate to severe head pain and used the actual device had more relief of migraine symptoms such as nausea, photophobia (sensitivity to light), and phonophobia (sensitivity to noise) than those who used the same device.

Side effects and contraindications: Possible side effects of using sTMS are momentary lightheadedness and/or ringing in the ears during treatment. People who should not use the device are those with a history of seizures or who have metal implants in their head, neck, or upper body, such as a pacemaker or defibrillator.

gammaCore Non-Invasive Vagus Nerve Stimulator

Originally approved to treat cluster headaches in April 2017, this device, sold as the gammaCore Sapphire, was given the go-ahead for treating (but not preventing) migraines in January 2018.

What it is: A handheld device that's roughly the size of a pack of cards with two stimulation surfaces on one end designed to be held against the skin in the vicinity of the vagus nerve in the neck.

How it works: The vagus nerve plays a significant role in regulating pain sensations. The gammaCore Sapphire stimulates this nerve, thereby block pain signals caused by migraine.

Effectiveness: In one significant study, compared to participants who used a sham device, those who used the gammaCore Sapphire within 20 minutes of the start of a migraine were more likely to be pain-free 30 minutes and 60 minutes after the attack.

Side effects and contraindications: Temporary side effects reported by people using gammaCore include discomfort and redness at the site of use, dizziness, and a tingling sensation. The gammaCore device has not been studied in children or women who are pregnant, and it is not considered safe for people who have an implantable medical device, carotid atherosclerosis, or who've had a cervical vagotomy (surgery to cut the vagus nerve in the neck).

A Word From Verywell

The brave new world of neurostimulation may well transform the management of migraine and other types of headaches as devices continue to be tested, found to be safe and effective, and gain approval from the FDA. That they don't lead to worsening of headaches in the way that many medications do is a huge advantage.

However, these devices are available only by prescription and can be pricey. What's more, insurance doesn't always cover the cost. Don't let that discourage you if you want to try one. By working with your doctor and health insurance provider, you may find a way to make neurostimulation treatment affordable.

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