External Trigeminal Nerve Stimulation for the Acute Treatment of Migraine: Open-Label Trial on Safety and Efficacy.

ABSTRACT

OBJECTIVE: The aim of the current study is to assess the safety and efficacy of external trigeminal nerve stimulation (e-TNS) via a transcutaneous supraorbital stimulator as an acute treatment for migraine attacks. MATERIALS AND METHODS: This was a prospective, open-labeled clinical trial conducted at the Columbia University Headache Center (NY, USA). Thirty patients who were experiencing an acute migraine attack with or without aura were treated with a one-hour session of e-TNS (CEFALY Technology) at the clinic. Pain intensity was scored using a visual analogue scale (VAS) before the treatment, after the one-hour treatment session, and at two hours after treatment initiation. Rescue migraine medication intake was recorded at 2 and 24 hours. RESULTS: Thirty patients were included in the intention-to-treat analysis. Mean pain intensity was significantly reduced by 57.1% after the one-hour e-TNS treatment (-3.22 ± 2.40; p < 0.001) and by 52.8% at two hours (-2.98 ± 2.31; p < 0.001). No patients took rescue medication within the two-hour observation phase. Within the 24-hour follow-up, 34.6% of patients used a rescue medication. No adverse events or subjective complaints were reported. CONCLUSIONS: The findings from this open-labeled study suggest that transcutaneous supraorbital neurostimulation may be a safe and effective acute treatment for migraine attacks, and merits further study with a double-blind, randomized, sham-controlled trial.