The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Migraine

Nu Eyne

Status: Completed

Conditions: Migraine

Treatments: Device: Elexir (trigeminal nerve electrical stimulator)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05301920

NE_MIG_001

Details and patient eligibility

About

The purpose of this study is to investigate the safety and effectiveness of trigeminal nerve electrical stimulator on reducing the frequency of migraine onset. It is applied to migraine patients and analyzes the results by comparing them before and after 4weeks.

Full description

• Duration of study period (per participant): Screening period (-6~0weeks), Intervention period (4weeks).
• Patient needs to visit site at least 3 times (Screening, Baseline, V4), V2 can be done with screening visit. V3 is tele-Visit.
• The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.
• During the study period, examination and treatment methods are carried out in the same way.

Enrollment: 20 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women over 19 years old
• Patients with migraine with or without migraine aura who meet ICHD-III (2018) diagnostic criteria 1.1 1.2
• Patients with history of migraine more than 1 year
• Patients who have headaches at least twice a month
• Those who do not take migraine prevention drugs from 12 weeks before screening to the end of the study, or who can maintain migraine prevention drugs during clinical trials without changing or adding additional migraine prevention drugs
• A person who voluntarily agreed to participate in this clinical trial

Exclusion criteria

• Those who are diagnosed with primary headaches (exception: low-frequency intermittent tension type headaches) and secondary headaches in addition to migraine headaches
• Those who are diagnosed with medication overuse headache in addition to migraine headaches
• Pregnant or lactating of women within 6months
• Among female subjects who are likely to be pregnant, those who disagree to contraception in a medically permitted manner during this clinical trial period. *Medically permitted contraception: condom, Oral contraception that lasted for at least 3 months, contraceptive injection, contraceptive implant, intrauterine device, etc
• Patients with mental illness who can interfere with their participation in the study.
• In the case where medical devices for clinical trials cannot be applied due to being sensitive to orbital nerve stimulation.
• Patients with a history of drug or alcohol abuse
• Those who participated in other clinical trials within 30 days of screening.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experimental Group

Experimental group

Description:

N=20 60Hz pulse electrical stimulation The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.

Treatment:

Device: Elexir (trigeminal nerve electrical stimulator)