- Feasibility and Safety of Elexir, an External Trigeminal Nerve Electrical Stimulator for the Acute Treatment of Migraine
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Soo-Im Jang, Soohyun Cho, Mi Ji Lee
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Received September 1, 2026 Accepted October 13, 2026 Published online October 23, 2026
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DOI: https://doi.org/10.62087/hpr.2026.0041
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 Abstract
- Purpose: External trigeminal nerve stimulation (eTNS) is a noninvasive neuromodulation technique used to treat migraine. This study evaluated whether Elexir (NuEyne Inc.), a newly developed eTNS device, was feasible and safe for use at home for the acute treatment of migraine.
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 the eTNS device themselves at home for 60 minutes during an eligible migraine attack. Feasibility of home use was assessed in terms of appropriate device use and treatment completion at both the participant and session levels; a completed session was defined by a stimulation duration of 60±5 minutes 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 the device during an eligible migraine attack, and 75 (94.9%; 95% CI, 87.7%–98.0%) completed at least one session, as confirmed by device logs. 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, of whom eight (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 at home for the acute treatment of migraine; no serious device-related AEs were observed. Establishing its efficacy will require further studies.
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