Neuromodulation devices are an innovative, non-drug approach to migraine treatment. By using electrical or magnetic stimulation to change nerve activity, these devices can help prevent or stop attacks for some people. Here’s what you need to know about how they work, who may benefit, and what challenges remain.
How neuromodulation devices treat migraine and who should consider them
Neuromodulation devices are advanced medical tools that can adjust the activity of the nervous system using electrical currents or magnets. Research has found that this technology may be effective in reducing migraine attacks and cluster headache attacks.
While most of these devices require a prescription, the Federal Drug Administration (FDA) has cleared two devices to be sold over the counter. All FDA-cleared devices are considered “minimal risk,” meaning no significant side effects are expected with use.
How neuromodulation works
Neuromodulation is achieved with a device that uses electrical currents or magnets, or temperature changes to influence brain activity. Some devices are designed to stop attacks that are already underway, while others are used preventively.
“They all work differently but the idea is that they’re changing the activity of the nerve pathways,” explained Dr. Rashmi Halker Singh, a professor of Neurology at the Mayo Clinic.
These devices are sometimes referred to as stimulators, although they often reduce brain activity rather than stimulate it. Neuromodulation devices can be electrical, temperature-altering, or magnetic. While most are portable, some require surgical placement.
Who should consider this type of treatment?
Neuromodulation can be a reasonable treatment option for many people living with migraine. These devices are generally safe for most patients and can complement other parts of a treatment plan, including lifestyle modifications, preventive medications, and acute treatments.
The main contraindications are for people with implanted devices like pacemakers, spinal cord stimulators, or other nerve stimulators.
“If you had a device that could stop a migraine attack without a drug, why wouldn’t you try that first, if it didn’t have side effects?” said Dr. Stewart Tepper, Vice President of External Research at the New England Institute for Neurology and Headache (NEINH).
Current FDA-cleared neuromodulation devices
There are now six FDA-cleared neuromodulation devices:
- CEFALY (External Trigeminal Nerve Stimulator, eTNS) – Worn on the forehead, this device delivers stimulation to the trigeminal nerve. It is FDA-cleared for both acute and preventive treatment of migraine, and is available over the counter.
Image of the CEFALY device - SAVI Dual™ (Single-Pulse Transcranial Magnetic Stimulator, ENeura device) – A handheld magnet placed on the back of the head that delivers brief magnetic pulses. It is FDA-cleared for both acute and preventive treatment of migraine.
Image of the SAVI Dual device - gammaCore (Non-invasive Vagus Nerve Stimulator, nVNS) – A handheld device applied to the neck to stimulate the vagus nerve. It is FDA-cleared for acute and preventive treatment of migraine, and for both acute and preventive treatment of cluster headache as well as other types of trigeminal autonomic cephalalgias.
Image of the gammaCore device - Nerivio (Remote Electrical Neuromodulation, REN) – A smartphone-controlled armband worn on the upper arm. It is FDA-cleared for both acute and preventive treatment of migraine in adults and adolescents.
Image of the Nerivio device - HeadaTerm 2 (Transcutaneous Electrical Nerve Stimulation, TENS) – A small portable forehead device worn to help prevent migraine. It is available over the counter.
Image of HeadaTerm 2 device - Relivion® MG (External Combined Occipital and Trigeminal Neurostimulation, eCOT-NS) – A headset that stimulates both the occipital and trigeminal nerves. It is FDA-cleared for the acute treatment of migraine in adults and is undergoing investigation for prevention.
Image of Relivion MG device
Consulting with a headache specialist about your individual situation is the best way to decide whether to try a new treatment method like a neuromodulation device. Find a headache specialist close to you using our Find a Doctor search tool, or learn more about other treatment options in our resource library.
Access and barriers
While promising, access remains a challenge. Most insurance providers do not cover neuromodulation devices, although the Veterans Affairs system covers some (such as Cefaly and one additional device). Some patients may also be able to use HSA or FSA dollars toward purchase.
Cost vary by device and may be a barrier for some people. “We need to develop [neuromodulation devices], but we also need to make them accessible to patients,” explained Dr. Halker Singh.
Expanding insurance coverage and increasing over-the-counter availability could open access to more people living with migraine. For some, concerns like medication overuse headache also make non-drug options especially valuable.
Special considerations
- Adolescents: Devices cleared for use in patients 12–17 include SAVI Dual™, Nerivio, and gammaCore.
- Pregnancy: No devices are FDA-cleared specifically for use during pregnancy. However, the FDA labeling for Nerivio (REN) now includes updated information allowing use during pregnancy under certain conditions. Additionally, the SAVI Dual™ device has published guidance from the UK regarding use in pregnancy. Because research is limited, use during pregnancy should always be considered carefully and discussed with a healthcare professional.
The future of neuromodulation
Neuromodulation offers a non-drug approach to treating migraine and cluster headache, and for many people, this is an appealing option. Specialists hope that as awareness grows and coverage expands, more people will have access to these tools.
Want to explore more about each device? Visit AMF’s Device Corner for up-to-date information and resources.
