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Completed

NCT Number: NCT05301920

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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in the number of days of moderate to severe headache

    Time frame: baseline, 4 weeks

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

Secondary outcomes

  1. Change in the number of headache days

    Time frame: baseline, 4 weeks

    Check the number of headache days in 4 weeks after the start of stimulation compared to the baseline

  2. Change in the frequency of headache days

    Time frame: baseline, 4 weeks

    Check the frequency of headache days in 4 weeks after the start of stimulation compared to the baseline

  3. Change in the frequency of taking the acute phase drug

    Time frame: baseline, 4 weeks

    Check the frequency of taking the acute phase drug in 4 weeks after the start of stimulation compared to the baseline

  4. Change in pain intensity when headache occurs

    Time frame: baseline, 4 weeks

    Check the change in pain intensity when headache occurs in 4 weeks after the start of stimulation compared to the baseline

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

    Time frame: baseline, 4 weeks

    Check the change in the headache effect assessment (HIT-6) in 4 weeks after the start of stimulation compared to the baseline

  6. Change in the migraine-related quality of life (MSQ 2.1) score

    Time frame: baseline, 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Nu Eyne Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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