NCT07451158进行中（未招募）不适用
Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine Treatment
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2025年11月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Reduce the intensity of migraine
研究概览
简要总结
Multicenter, double-blind, and randomized controlled trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged between 18 and 75;
- •According to the diagnostic criteria of the International Classification of Headache Disorders (ICHD-III), the diagnosis is episodic migraine with or without aura or probable migraine with or without aura;
- •The duration of the illness is at least 12 months;
- •The age of onset of the first migraine is less than 50 years old;
- •During the screening period of 4 weeks, there were 2-8 episodes of headache, with moderate or severe pain intensity;
- •Before screening, the subjects should provide their previous medical records as much as possible;
- •Participants can distinguish migraines from other conditions, including tension-type headaches and cluster headaches
- •Understand and adhere to the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing;
排除标准
- •Pregnant and lactating women;
- •Suffering from arrhythmia or other heart diseases (such as ischemic heart disease, coronary artery spasm, myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, angina pectoris);
- •Have undergone surgery within the past 6 months;
- •Recent stroke or transient ischemic attack;
- •Equipped with a pacemaker;
- •History of previous seizures;
- •Metal implants in the head;
- •Patients with clinical evidence of brain damage;
- •Chronic pain associated with other diseases;
- •Use antipsychotic drugs;
- •Those who are intolerant to neuroregulators;
- •Employees of the research center or their immediate family members.
- •There is a condition or anomaly that the investigator believes may affect patient safety or data quality
研究组 & 干预措施
Group B
Placebo Comparator
Fake Stimulus Group
干预措施: Fake Stimulus (Device)
Group A
Experimental
Transcetaneous Electrical Stimulation
干预措施: Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation (Device)
结局指标
主要结局
Reduce the intensity of migraine
时间窗: Baseline and 2 hours post-treatment
After treatment, participants rated their headache intensity as 0 (no pain =0 points, mild =1 point, moderate =2 points, severe =3 points).
the pre-selected accompanying symptoms
时间窗: Baseline and 2 hours post-treatment
Participants no longer experienced the pre-selected accompanying symptoms (e.g., nausea, vomiting, photophobia, phonophobia) after 2 hours of treatment.
次要结局
- pain relief(Baseline and 2 hours post-treatment)
- returned to normal function(Baseline and 2 hours post-treatment)
- Use of acute treatment drugs(Baseline and 24 hours post-treatment)
- recurrence of migraine(Baseline and 2-24 hours post-treatment)
- recurrence of migraine2(Baseline and 2-48 hours post-treatment)
- pain-free status(Baseline and 15,30,45,60, and 90 minutes post-treatment)
- symptoms free(Baseline and 15,30,45,60, and 90 minutes post-treatment)
研究者
研究点 (1)
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