clinical topic updates

Neuromodulation in Acute and Preventive Migraine Treatment Strategies

by Deborah I. Friedman, MD, MPH, FAAN

Overview

Neuromodulation is emerging as a safe and effective acute and preventive treatment strategy for patients with migraine. Our featured expert discusses the use and efficacy of various neurostimulation devices for migraine treatment.

Expert Commentary

Deborah I. Friedman, MD, MPH, FAAN, FAHS

Professor of Neurology and Ophthalmology
University of Texas Southwestern Medical Center
Dallas, TX

“All of these devices have been shown in studies to be safe and reasonably effective. The most significant disadvantage of neuromodulation may be financial.”

Deborah I. Friedman, MD, MPH, FAAN

Neuromodulation is one of several nonpharmacologic therapies, in addition to biofeedback, cognitive behavioral therapy, stress management, and relaxation therapy, that have been developed for migraine. Some forms of neuromodulation have both abortive and preventive applications.

The Cefaly external trigeminal nerve stimulation (e-TNS) device (CEFALY Technology) is a transcutaneous supraorbital stimulator that is US Food and Drug Administration (FDA) approved for the acute and preventive treatment of migraine headache in patients aged 18 years and older with migraine with or without aura; it is now available without a prescription. The triangular-shaped stimulator is placed on the patient’s forehead with a self-adhesive electrode. The device has 2 different settings and may be used daily in 20-minute sessions in the case of prevention or acutely at the onset or during a migraine.

The gammaCore Sapphire (electroCore) is an external, hand-held, vagus nerve stimulator that is applied to the side of the neck. It is available by prescription and has applications in adults for the acute and preventive treatment of migraine headache and for the acute and adjunctive preventive treatment of cluster headache. The FDA review was based on a clinical comparison of probable risks and benefits to health, and it determined probable benefits to health based on clinical evidence and patient preference information that were submitted to the FDA.

A third, more recent option in neuromodulation is Nerivio (Theranica Bio-Electronics). This is a novel device that is authorized by the FDA for the acute treatment of migraine; it is currently under evaluation for preventive therapy as well. Nerivio is worn on the arm and is patient controlled via a smartphone to deliver transcutaneous electrical pulses to modulate pain signals. The device is available on a month-to-month subscription basis without a prescription.

The eNeura sTMS (single pulse transcranial magnetic stimulation) device delivers magnetic, rather than electrical, stimulation. The battery-powered device is held next to the back of the head to cradle the base of the skull. Pressing a button starts the treatment, delivering a single pulse of magnetic fields through the skull to interrupt the electrical activity associated with migraine. eNeura filed for bankruptcy on August 7, 2020, and the device is currently unavailable, but it is expected to return to the market under different ownership.

I do not have a strong preference for any particular device among the available options, as all of these devices have been shown in studies to be safe and reasonably effective. So, these may be viable options for certain patients (eg, those who prefer not to take medication or have contraindications to medications). The most significant disadvantage of neuromodulation may be financial. In fact, a key consideration is that, for some people, the initial cost of the device may be prohibitive. As these are FDA cleared as medical devices, they are not always covered by insurers, resulting in a significant investment of as much as several hundred dollars plus the cost of monthly fees for ongoing use or electrode pads, which must be replaced periodically. Neuromodulation is also not cleared for use in children.


Disclosure: Dr Friedman reported serving as a consultant and receiving grant support from electroCore, and serving as a consultant for Theranica.

References

Barker AT, Shields K. Transcranial magnetic stimulation: basic principles and clinical applications in migraine. Headache. 2017;57(3):517-524. doi:10.1111/head.13002

Beh SC. External trigeminal nerve stimulation: potential rescue treatment for acute vestibular migraine. J Neurol Sci. 2020;408:116550. doi:10.1016/j.jns.2019.116550

Birlea M, Penning S, Callahan K, Schoenen J. Efficacy and safety of external trigeminal neurostimulation in the prevention of chronic migraine: an open-label trial. Cephalalgia Reports. 2019;2:1-10. doi:10.1177/2515816319856625

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

electroCore. Instructions for use for gammaCore Sapphire . Accessed February 1, 2021. https://www.gammacore.com/wp-content/themes/gammacore-p2/pdf/gammacore-IFU.pdf

Nerivio. Nerivio® drug-free acute migraine treatment. Accessed February 1, 2021. https://www.getnerivio.com/products/nerivio/

Rapoport AM, Lin T. Device profile of the Nerivio™ for acute migraine treatment: overview of its efficacy and safety. Expert Rev Med Devices. 2019;16(12):1017-1023. doi:10.1080/17434440.2019.1695599

Riederer F, Penning S, Schoenen J. Transcutaneous supraorbital nerve stimulation (t-SNS) with the Cefaly® device for migraine prevention: a review of the available data. Pain Ther. 2015;4(2):135-147. doi:10.1007/s40122-015-0039-5

Starling AJ, Tepper SJ, Marmura MJ, et al. A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE study). Cephalalgia. 2018;38(6):1038-1048. doi:10.1177/0333102418762525

Stilling JM, Monchi O, Amoozegar F, Debert CT. Transcranial magnetic and direct current stimulation (TMS/tDCS) for the treatment of headache: a systematic review. Headache. 2019;59(3):339-357. doi:10.1111/head.13479

Yarnitsky D, Dodick DW, Grosberg BM, et al. Remote electrical neuromodulation (REN) relieves acute migraine: a randomized, double-blind, placebo-controlled, multicenter trial. Headache. 2019;59(8):1240-1252. doi:10.1111/head.13551

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