Neuromodulation Devices in Migraine: The Latest

Jessica Ailani, MD, FAHS


January 08, 2019

Editorial Collaboration

Medscape &

Migraine is a neurobiological disease characterized by episodic disabling attacks of moderate to severe head pain, associated with nausea and/or vomiting and light or sound sensitivity; it affects up to 12% of the US population.[1,2] Untreated, attacks reduce an individual's ability to function, creating a significant impact on work and family activities. Treatment to abate attacks is required by most patients, though studies show that only a portion of patients take medications to treat migraine attacks].[3] Up to 40% of people with migraine would benefit from additional treatment to reduce the frequency of migraine—ie, a preventive—but studies show that only 13% of people in the United States use migraine prevention measures.[2] Treatment options for migraine vary from over-the-counter medications to prescription treatments. Prescription medications are often stopped due to lack of tolerance and poor efficacy as stated by patients.[4]

Neuromodulation is a technique that employs stimulating the nervous system via electric currents or a fluctuating magnetic field to modulate pain pathways.[5] This type of treatment can have an immediate effect, making it useful for aborting migraine attacks. Daily scheduled use can modulate the nervous system and allow for a preventive effect. Numerous devices have been studied for the acute and preventive treatment of migraine. They offer patients an option that is well tolerated and may be used for both acute and preventive needs in migraine. Here is an overview of available devices approved by the US Food and Drug Administration (FDA).

The Latest FDA-Approved Neuromodulation Devices


Transcutaneous supraorbital nerve stimulation (STS), also known as Cefaly, was first studied as a preventive option in episodic migraine patients, with findings of reduction in headache days in participants with migraine.[6] A larger study was conducted, showing that once-daily use of the device for 3 months resulted in 30% reduction in migraine days in the active group.[7] The most frequent adverse event was paresthesia in the area of stimulation; it was mostly mild and reversible, although some participants found it intolerable.

STS has also been found effective for the acute treatment of migraine in a randomized controlled trial.[8] An open-label trial of the use of STS for the prevention of chronic migraine has also shown reduction in headache days over 4 months with use of STS for 20 minutes per day.[9]


Single-pulse transcranial magnetic stimulation (sTMS) is delivered with a hand-held device that creates a fluctuating magnetic field which triggers an electric current that modifies cortical excitability. In the United States, it was first FDA-approved for acute use in patients with migraine with aura, based on a randomized controlled trial showing higher pain-free rates at 2 hours in the treatment versus sham group.[10]  A multicenter, open-label US study has shown sTMS to be beneficial in the prevention and acute treatment of episodic and chronic migraine.[11] Treatment is well tolerated, with limited adverse events reported.


Noninvasive vagal nerve stimulation (nVNS), commercially available as gammaCore, is known to be helpful in epilepsy and depression.[12] It was incidentally noted that patients receiving invasive VNS were reporting reduced migraine attacks, though the mechanism for this is still unclear. nVNS has been FDA-approved for the acute treatment of episodic migraine. A randomized controlled trial of nVNS for the treatment of migraine attacks showed that it was well tolerated and produced higher pain-free and pain-relief rates at 2 hours compared with sham stimulation. It was also shown to have reproducible effects when used for multiple migraine attacks.[12]


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