NCT02438553已完成不适用
A Prospective, Randomized, Single Blind, Parallel-group, Placebo Controlled Clinical Study to Evaluate the Short-term Effectiveness of Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation (OS-TNS) in Reducing Migraine Related Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain visual analogue scale (VAS)
研究概览
简要总结
The purpose of this study is to evaluate the short-term effectiveness of combined occipital and supraorbital transcutaneous nerve stimulation in reducing migraine related pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with confirmed diagnosis of migraine headache without aura or with typical migraine with aura (ICHD-II code 1.2.1 or 1.1).
- •Subjects with 1-6 migraine episodes per month in the last 2 months.
- •The subject is capable of understanding the study and to sign an informed consent.
排除标准
- •Subjects who have concomitant epilepsy.
- •History of neurosurgical interventions.
- •Subjects with metal implants or shrapnel in their head, except for dental implants.
- •Subjects with implanted cardiac pacemaker, neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- •History of drug abuse or alcoholism.
- •History of medications overuse headache.
- •Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
- •Skin lesion or inflammation at the region of the stimulating electrodes.
- •Personality or somatoform disorder.
- •Pregnancy or Lactation.
- •Women of reproductive age not using efficient contraceptive method.
- •History of cerebrovascular event.
结局指标
主要结局
Pain visual analogue scale (VAS)
时间窗: 20-60 minutes of treatment.
The primary endpoint will be defined based on relative change (%) in pain VAS score from baseline to end of treatment without using pain relief medication.
次要结局
- Time until use of pain relief medication.(Baseline- 24 hours.)
- Percentage of subjects who completed the treatment.(Baseline-20 minutes of treatment)
- Sustained "Responder" rate at 24 hours post treatment(Baseline, 24 hours post treatment)
- "Responder" rate at 20-60 minutes of treatment.(20-60 minutes of treatment.)
- "Headache relief" rate- at 2 hours(Baseline, 2 hours)
- Sustained "headache relief" at 24 hours(Baseline, 24 hours)
- Sustained pain freedom at 24 hours(Baseline, 24 hours)
- Functional disability change 2 hours from end of treatment(Baseline, 2 Hours post treatment)
- Pain free at 2 hours(Baseline, 2 hours)
- "Responder" rate at 15 minutes of treatment(Baseline, 15 minutes of treatment)
- Presence of nausea, vomiting, photophobia, phonophobia.(Baseline- 24 hours.)
- Global impression of effect(Baseline- 24 hours.)
研究者
研究点 (1)
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