Post-marketing Clinical Trial of Elexir(Trigeminal Nerve Electrical Stimulator) for the Acute Treatment of Migraine

Inclusion Criteria:

1. Men and women19 to 65
2. A person who meet the ICHD-III (2018) criteria for migraine without aura and migrainewith aura (ICHD-III sections 1.1, 1.2) However, typical aura, migraine with brainstemaura, and hemiplegic migraine without headache are excluded.
3. Having a history of migraine for more than 1 year
4. Migraine onset before the age of 50
5. Having between 2 and 8 migraine headaches* per month for 2 months in each of the twomonths prior to screening
6. A person who voluntarily agreed in writing to participate in this clinical trial

• Migraine headache: Migraine attack lasting 4 to 72 hours (if untreated orinadequately treated), unilateral pulsating pattern, moderate or severe painintensity (Grade 2 or 3 on the four-point Likert Scale), nausea, and /or headacheaccompanied by photophobia and phonophobia

Exclusion Criteria:

1. A person who has difficulty distinguishing between migraine and tension-type headache
2. A person who suffer from headaches more than 15 days a month
3. A person who underwents supraorbital nerve block within 4 months before the screeningvisit
4. A person who received Botox treatment within 4 months before the screening visit
5. Modification of a migraine prophylaxis treatment in the previous 3 months
6. A person diagnosed with other primary headaches excluding tension-type headaches lessthan 4 times a month
7. A person diagnosed with secondary headaches, including medication overuse headache
8. History of drug or alcohol abuse
9. A person judged to have other reasons for prohibiting the use of medical devices forclinical trials: A person implanted with metal or electronic devices such as head andneck implants, including deep brain stimulation devices, and persons implanted withimplantable and wearable pacemakers. Those included in product precautions andcontraindications (not applicable to dental implants)
10. Pregnant or lactating women
11. Among female subjects with childbearing potential, those who do not agree to maintainabstinence(not having sexual intercourse with the opposite sex) or to usecontraception using a medically acceptable method* during the period of this clinicaltrial *Medically acceptable contraceptive methods: condoms, oral contraception for at least 3 months, use of injectable or insertable contraceptives, installation of anintrauterine contraceptive device, etc.
12. A person who participated in another clinical trial within 30 days of the screeningvisit
13. In other cases where the researcher determines that participation in the study isdifficult (If you do not understand or cannot read the consent form for this clinicaltrial, etc.)