Nerve stimulation intervention may reduce number of headache days in migraine patients

Commercial-stage bioelectronic medicine company electroCore Inc. announced its noninvasive vagus nerve stimulation intervention for migraine prevention reduced the number of monthly headache days.

Results of the multicenter, randomized, double-blind, sham-controlled trial conducted across 27 sites in the U.S. were published in Cephalalgia. Researchers enrolled 336 individuals and randomly assigned 231.

Adults with migraine, with or without aura, completed a 4-week diary run-in period, after which researchers randomly assigned them to active noninvasive vagus nerve stimulation (nVNS) or sham therapy during a 12-week double-blind period.

Results showed a decrease in the number of monthly headache days of 4.6 for stimulation compared with 3 for sham (P = .05). A total of 44.87% of participants in the intervention group had greater than 50% reduction in monthly migraine days compared with 26.81% for the sham group (P = .05). Researchers noted an improvement of -4.9 points for the intervention vs. -2.3 for sham (P < .05) in quality of life, according to the Headache Impact scale. Among patients with migraine with aura, the number of headache days dropped by 5.5 days in the intervention group vs. 2.7 days in the sham group, which represented a therapeutic gain of greater than 100% compared with sham.

“We are pleased to have added to the data that helps suggest the types of migraine patients who could likely benefit most from nVNS,” study author Umer Najib, MD, program director of the Headache Medicine Fellowship Program at West Virginia University and first author of the paper, said in a press release. “The safety and tolerability of nVNS is such that it can be used as a stand-alone or adjunctive treatment, depending on the needs of the patient, and its flexibility allows health care providers to consider it for many of their patients.”

Reference:

Najib U, et al. Cephalalgia. 2022;doi:10.1177/03331024211068813.