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

NCT05301920 | Completed

• 1 other identifier: NE_MIG_001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Change in the number of days of moderate to severe headache

  Check the number of days of moderate to severe headache at 4 weeks after start compared to baseline

  baseline, 4 weeks

Secondary Outcomes (6)

• Change in the number of headache days

  baseline, 4 weeks

• Change in the frequency of headache days

  baseline, 4 weeks

• Change in the frequency of taking the acute phase drug

  baseline, 4 weeks

• Change in pain intensity when headache occurs

  baseline, 4 weeks

• Change in the headache effect assessment (HIT-6) score

  baseline, 4 weeks

Study Arms (1)

Experimental Group

EXPERIMENTAL

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.

Device: Elexir (trigeminal nerve electrical stimulator)

Interventions

Elexir (trigeminal nerve electrical stimulator) DEVICE

Elexir performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.

Experimental Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nu Eyne Co., Ltd.: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: October 8, 2021
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)