Nerve Stimulation Medical Devices for Migraine Headache

Non-Drug Options for Preventing Attacks and Relieving Pain

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Today, there are more options for managing migraines than ever before. There are a growing number of medical devices that help prevent headaches and relieve pain by affecting neuronal activity in the brain. They are known as neuromodulation devices. Among the advantages of such neuromodulation devices is the absence of medication side effects, including medication overuse headaches.

Three of these devices have been cleared by the FDA and already are already in use. Some require a prescription, but some are available over the counter (OTC). These devices use different approaches to affecting neuronal activity and are known as e-TNS, sTMS, and non-invasive vagus nerve stimulation.

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

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External Trigeminal Nerve Stimulation (e-TNS)

Sold under the brand name 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. Cefaly was the first neurostimulator approved by the FDA for migraine prevention. It's now approved to both treat and prevent migraines. It's available over the counter.

What it is: Cefaly 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.

How it works: The device generates small pulses of electricity that stimulate the trigeminal nerve, which plays a role in migraine headaches.

Stimulating the supraorbital and supratrochlear nerves
 ​Verywell / Cindy Chung

Effectiveness: Cefaly's small clinical trials have found that the device reduces migraine frequency in a significant portion of people. The trials found very few adverse effects, making it a good option for people looking for non-pharmaceutical migraine prevention.

A trial to evaluate the effect of Cefaly in reducing pain levels during a migraine found that 59% of the 99 participants had less pain after one hour of wearing the device.

Side effects and contraindications: In Cefaly's study, only four people who used Cefaly had minor side effects. Three were unable to tolerate the feeling of the device on the forehead and one experienced nausea. In surveys, some people reported fatigue during and after treatment sessions, headache after a session, and skin irritation.

Single Pulse Transcranial Magnetic Stimulator (sTMS)

The sTMS device is FDA-approved to treat migraine with aura and migraine without aura. It is sold under the brand name eNeura and is only available with a doctor's prescription.

What it is: The eNeura sTMS mini 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. This powerful device can be rented for three months at a time.

How it works: The primary cause of the visual aura that precedes a migraine is a wave of unusual electrical activity in the brain, a phenomenon known as cortical spreading depression (CSD). The sTMS device uses pulses of magnetic energy to disrupt this wave.

Effectiveness: In the study that led the FDA to approve the sTMS, people who had migraine with aura were divided into two groups. One set of subjects was given an sTMS device and the other group was given a fake device. Both groups were told to use their device for up to 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 other migraine symptoms such as nausea, photophobia (sensitivity to light), and phonophobia (sensitivity to noise) than those who used the fake device.

Side effects and contraindications: Possible side effects of using sTMS are momentary lightheadedness and ringing in the ears during the 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.

Inform your doctor about all your pre-existing conditions to make sure it's safe for you to use a neuromodulation device.

gammaCore Non-Invasive Vagus Nerve Stimulator

Originally intended to treat cluster headaches, the gammaCore Sapphire is now FDA-cleared to treat and prevent migraines in adults.

What it is: It's a handheld device that's roughly the size of a pack of cards and has 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 blocking pain signals caused by migraine.

Effectiveness: In one study, compared to participants who used a fake 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 developed. They have an advantage over pharmacutical treatments because they don't cause side effects or rebound headaches. However, these devices can be pricey and they're not always covered by health insurance.

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  2. Chou DE, Shnayderman Yugrakh M, Winegarner D, Rowe V, Kuruvilla D, Schoenen J. Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial. Cephalalgia. 2019;39(1):3-14. doi: 10.1177/0333102418811573

  3. Lipton RB, Dodick DW, Silberstein SD, et al. Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial. Lancet Neurol. 2010;9(4):373-80. doi:10.1016/S1474-4422(10)70054-5 

  4. Tassorelli C, Grazzi L, de Tommaso M, et al. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Neurology. 2018;91(4):e364-e373. doi:10.1212/WNL.0000000000005857

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