NCT05301920已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in the number of days of moderate to severe headache
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in the number of days of moderate to severe headache
时间窗: baseline, 4 weeks
Check the number of days of moderate to severe headache at 4 weeks after start compared to baseline
次要结局
- 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)
- Change in the migraine-related quality of life (MSQ 2.1) score(baseline, 4 weeks)
研究者
研究点 (2)
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