Clinical trial NCT05301920: The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Migraine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Nu Eyne Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the number of days of moderate to severe headache
timeFrame: baseline, 4 weeks
Secondary outcomes:
measure: Change in the number of headache days
timeFrame: baseline, 4 weeks
measure: Change in the frequency of headache days
timeFrame: baseline, 4 weeks
measure: Change in the frequency of taking the acute phase drug
timeFrame: baseline, 4 weeks
measure: Change in pain intensity when headache occurs
timeFrame: baseline, 4 weeks
measure: Change in the headache effect assessment (HIT-6) score
timeFrame: baseline, 4 weeks
measure: Change in the migraine-related quality of life (MSQ 2.1) score
timeFrame: baseline, 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: