Noninvasive Single-Pulse Stimulation Device Can Help Prevent Migraines, Study Finds

A noninvasive single-pulse transcranial magnetic stimulation (sTMS) may be an effective, well-tolerated treatment option for migraine prevention, according to study findings.

eNeura’s SpringTMS device originally received FDA approval for the acute treatment of migraine with aura in 2014. The stimulation device delivers an electrical current through layers of the scalp to the superficial layers of the cortex. Seeking to expand the indication to include migraine prevention, researchers assessed the effectiveness of the device in the eNeura SpringTMS Post-Market Observational US Study of Migraine.

“Migraine is a highly prevalent neurologic disease affecting over 38 million people in the United States. It is the leading cause of neurological disability and the seventh most disabling medical illness in the world,” wrote the authors of the study. “Currently available acute and preventive medications are often associated with suboptimal efficacy, tolerability, and adherence.”

The study, which was published in Cephalalgia, was a multicenter, prospective, open-label, observational study assessing 132 patients who experienced migraine lasting 4 hours or more at least 4 days per month. Participants were enrolled from December 2014 to March 2016 and completed a 28-day baseline headache diary for the researchers to establish baseline headache days prior to intervention.

Of the 132 patients, 90% had episodic migraine, and 10% had chronic migraine. Participants underwent the 3-month treatment protocol, which consisted of both preventive and acute treatment. For treatment, participants put the portable sTMS device on the back of their head and pressed a button to deliver the pulse. Preventive daily treatment consisted of 4 pulses twice a day. Acute treatment consisted of 3 consecutive pulses repeated up to 3 times for each attack.

At baseline, there were 9.06 headache days. After 3 months of treatment, patients averaged 3 fewer migraines per month, regardless of migraine type. Results also showed that 46% of participants had a greater than 50% reduction in the number of headache days, as well as a significant reduction in disability and the amount of days of acute medication use.

In days of acute medication use, participants experienced a 2.93 reduction per month. Also examining the difference from baseline in total headache days of any pain intensity, researchers observed a reduction in 3.16 days per month. Throughout the treatment period, there were no serious adverse events reported for participants who used the device.

As nonmedication adherence commonly leads to poor patient outcomes, complexity of treatment regimens can play a key role in declining adherence, the authors noted. They wrote: “The simplicity, efficacy, and tolerability of sTMS, combined with its dual utility as both an acute and preventive treatment option, may possibly increase adherence and compliance and improve patient outcomes.”

Based on the results of the study, in combination with a previous randomized controlled trial and results from a United Kingdom program, the FDA approved the sTMS device for the acute and preventive treatment of migraine.

Reference

Starling AJ, Tepper SJ, Marmura MJ, et al. A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study). [published online March 4, 2018]. Cephalalgia. doi: 10.1177/0333102418762525.