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

A Single-center, Open-label, Clinical Effect Observational Study to Evaluate the Safety and Effectiveness of Reducing the Frequency of Migraine Onset Through Clinical Application of Elexir (Trigeminal Nerve Electrical Stimulator) in Migraine Patients

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Device: Elexir (trigeminal nerve electrical stimulator)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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); Elexir performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of headache days	Check the number of headache days in 4 weeks after the start of stimulation compared to the baseline	baseline, 4 weeks
Change in the frequency of headache days	Check the frequency of headache days in 4 weeks after the start of stimulation compared to the baseline	baseline, 4 weeks
Change in the frequency of taking the acute phase drug	Check the frequency of taking the acute phase drug in 4 weeks after the start of stimulation compared to the baseline	baseline, 4 weeks
Change in pain intensity when headache occurs	Check the change in pain intensity when headache occurs in 4 weeks after the start of stimulation compared to the baseline	baseline, 4 weeks
Change in the headache effect assessment (HIT-6) score	Check the change in the headache effect assessment (HIT-6) in 4 weeks after the start of stimulation compared to the baseline	baseline, 4 weeks
Change in the migraine-related quality of life (MSQ 2.1) score	Check the migraine-related quality of life (MSQ 2.1) change in 4 weeks after the start of stimulation compared to the baseline MSQ 2.1 measures the impact of migraine across three essential aspects. The MSQ total and scale score varies between 0 and 100 with higher scores indicating higher impact.	baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Nu Eyne Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: NE_MIG_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No