Feasibility and Safety of Elexir, an External Trigeminal Nerve Electrical Stimulator for the Acute Treatment of Migraine

Purpose: External trigeminal nerve stimulation (eTNS) is a noninvasive neuromodulation technique used to treat migraine. This study evaluated the feasibility and safety of Elexir®, a newly developed eTNS device, for the acute treatment of migraine at home.Methods: This prospective, randomized, sham-controlled postmarketing study enrolled participants with migraine who reported 2–8 attacks per month. Participants were assigned 1:1 to verum or sham stimulation and instructed to use Elexir® at home for 60 minutes during an eligible migraine attack. Feasibility of home use was assessed in terms of per-protocol use and treatment completion at both the participant and session levels; session completion was defined by 60 (±5)-minute stimulation recorded in the device log. Assessments also included adverse events (AEs) and exploratory efficacy outcomes: changes in pain intensity, pain freedom and relief, and resolution of associated symptoms.Results: Of the 100 randomized participants, 79 formed the home-use population. Within this population, 78 (98.7%; 95% confidence interval [CI], 93.2%–99.8%) used Elexir® during an eligible migraine attack, and 75 (94.9%; 95% CI, 87.7%–98.0%) completed at least one session. Of the 139 treatment sessions conducted at home, 103 (74.1%; 95% CI, 66.2%–80.7%) were completed within the protocol-defined duration. Ten participants (10.0%) reported AEs and eight participants (8.0%) reported device-related AEs. No serious device-related AEs were observed. The groups did not differ significantly in exploratory efficacy outcomes.Conclusion: These findings support the feasibility of using Elexir® for the acute treatment of migraine; no serious device-related AEs were observed. Further studies are required to support efficacy.