Health

Trigeminal Nerve Stimulation May Head Off Migraine With Vertigo

External trigeminal nerve stimulation (eTNS) may be an effective and well-tolerated rescue therapy for acute vestibular migraine (VM) attacks, a small retrospective study suggests.

For 19 patients in the midst of an acute VM episode, a single, 20-minute eTNS session using the Cefaly eTNS device (Cefaly Technology, Seraing, Belgium) successfully ameliorated vertigo and headache.



The Cefaly device. Cefaly

“There are no approved treatments for vestibular migraine. Some of my patients find that [eTNS] is helpful for both rescue and prevention,” Shin C. Beh, MD, assistant professor of neurology, University of Texas, Southwestern Medical Center, Dallas, told Medscape Medical News.

The study was published online October 25 in the Journal of Neurological Sciences.

Nondrug Option

The US Food and Drug Administration (FDA) approved the Cefaly device for migraine prevention in 2014 and for migraine abortive therapy in 2018.

The device, which resembles a plastic headband that is worn across the forehead and above the ears, stimulates the trigeminal nerve using a self-adhesive electrode in the center of the forehead.

During a 1-year period, 19 patients (17 women; median age, 48 years) who experienced acute VM attacks were seen at a single center. Diagnosis of VM was based on the International Classification of Headache Disorders, 3rd Edition; diagnostic criteria include that a patient have at least five episodes of vestibular symptoms of moderate or severe intensity lasting between 5 minutes and 72 hours.

All patients underwent a 20-minute treatment session of eTNS using the Cefaly device as a rescue therapy during an acute VM attack. The median estimated time from onset of VM episode to eTNS was 4 hours.

The entire cohort reported improvement in vertigo severity. Average vertigo severity was 6.6 on the 10-point Visual Analogue Scale before eTNS and fell to 2.7 following treatment. Average improvement in vertigo was 61.3%.

Fourteen patients had headache during the VM episode. Average headache severity was 4.8 before eTNS and dropped to 1.4 following treatment. Average improvement in headache was 77.2%.

Results of neuro-otologic examination were normal during VM attacks in all but one patient, who experienced spontaneous upbeat nystagmus. The nystagmus resolved after eTNS. Treatment also led to improvement of eye pressure, head pressure, and chronic facial pain.

No intolerable side effects were reported. All 19 patients completed the 20-minute eTNS treatment. None reported worsening of their symptoms.

All but two patients were followed up for 3 to 6 months after the initial treatment. Eight continued to use eTNS with the Cefaly device for VM prevention and rescue; five preferred to continue using pharmacologic agents for VM. Four patients were unable to afford the device.

“As with any small, open-label studies, the effect of placebo cannot be excluded and the results are not generalizable. However, our study provides proof of concept that supports a double-blind, randomized, sham-controlled clinical trial of eTNS in VM,” Beh writes in his report.

Unmet Need

Commenting on the findings for Medscape Medical News, Noah Rosen, MD, director of Northwell Health’s Headache Center in Great Neck, New York, said that there is very little evidence for any treatment being beneficial for VM and that any potential treatment is useful.

“For those with vestibular migraine, the associated symptoms can be as bad as the pain, and if this device can help address that, then people will benefit,” said Rosen.

“Cefaly is a transcutaneous electrical nerve stimulator device that has shown some evidence for acute treatment and prevention of migraine. While it is a peripheral stimulation device, it is quite different than the vagal nerve–stimulating gammaCore device [electroCore]. Side effects of these types of treatment are low, but so is the quality of evidence,” he added.

Lauren Natbony, MD, assistant professor of neurology, Center for Headache and Facial Pain, and director, Headache Medicine Fellowship, Icahn School of Medicine at Mount Sinai, in New York City, also thinks the study is noteworthy.

“While we try different medications to relieve acute vestibular migraine attacks, the results are quite variable. In addition, many medications have unpleasant side effects. Thus, having a nonmedication option that is effective for acute attacks could be life changing for many vestibular migraine sufferers,” said Natbony.

She added that it’s “encouraging that benefit was found even after the vestibular migraine attack had been ongoing for hours to days. Many oral medications are required at attack onset for benefit. Thus, the Cefaly may be useful both as a first-line treatment as well as a backup if medications fail.”

Three versions of the Cefaly device are now available. The Cefaly DUAL device, which includes modes for both prevention and abortive therapy, costs $499; the ACUTE device and the PREVENT device each cost $349.

“The device is not covered by insurance, so there is a cost factor to using this treatment,” Natbony said.

The study had no funding. Beh, Rosen, and Natbony report no relevant financial relationships.

J Neurol Sci. Published online October 25, 2019. Abstract

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