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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05301920
• Other study ID #: NE_MIG_001
• Status: Completed
• Phase: N/A
• Start date: October 8, 2021
• Est. completion date: January 28, 2022

Study information

• Verified date: December 2023
• Source: Nu Eyne Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Nu Eyne Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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