Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain
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
- Mean change in pain score
研究概览
简要总结
Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-100 years, inclusive
- •Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria
- •4-14 migraine days per month
- •Ability to provide informed consent
- •Demonstrates no contraindication to the use of electrical nerve stimulation
- •Capable and willing to follow all study-related procedures
排除标准
- •Currently pregnant or breastfeeding, pregnant within the past 6 months or intends to become pregnant during the enrollment period
- •Diagnosis of chronic migraine or other forms of primary or secondary headache disorders, including medication overuse headache per International Headache Society diagnostic criteria
- •Any medical condition that would, in the opinion of the investigator, make the subject ineligible
- •Has received botulinum toxin injections within the past 3 months
- •Is currently implanted with an electrical and/or neurostimulator devic, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, sacral stimulator, bone growth stimulator, or cochlear implant
- •Use of investigational drug/device therapy within the past 4 weeks
- •Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination (including bleeding disorders, anticoagulant medications and peripheral neuropathy)
- •No changes in preventive medications (or other medications determined to potentially interfere with the study) in the previous 30 days and no intent to change it during the study
结局指标
主要结局
Mean change in pain score
时间窗: 4 months
We will also assess the change in migraine pain before versus after treatment with the 100-mm Visual Analogue Scale (VAS), which is a continuum scale that patients can quantify their pain from none (0 mm) to extreme (100 mm) for both treatment sites. The mean score for each patient cohort will be calculated. We will also perform a sub analysis on women versus men.
Percent of subjects who are responders
时间窗: 4 months
For each subject treatment effectiveness will be assessed by both achieving pain relief (if the pain decreases from a 4-point visual rating scale (VRS) of 'severe' or 'moderate' at pre-treatment to 'mild' or 'none' at 120-min post-treatment) or pain-free ('none') status. The percent of subjects that experience a significant reduction in pain relief score (VRS) will be calculated for the verum and sham treatment sites.
次要结局
未报告次要终点