NCT00747812终止2 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Occipital Nerve Stimulation for Drug Refractory Migraine
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Number of Hours of Headache
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be diagnosed with multiple migraines per month of moderate to severe intensity;
- •Be refractory to medication;
- •Be an appropriate candidate for the surgical procedures required fo this study;
- •Be willing and able to comply with all study related procedures;
- •Be capable of reading and understanding patient information materials and giving written informed consent.
排除标准
- •Have onset of headache after age 50;
- •Are current substance abusers (including alcohol and illicit drugs);
- •Have a significant psychiatric disorder;
- •Have previously been treated with occipital nerve stimulation (either temporary trial or permanent implant);
- •Have had nerve stimulation for pain relief.
- •Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment;
- •Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radiofrequency procedure currently in effect.
- •Have a condition currently requiring or likely to require the use of MRI or diathermy;
- •Have an active implantable device;
- •Are pregnant or lactating or planning to become pregnant in the next 14 months;
- •Have participated in any drug or device trial in the last 4 weeks or plant to participate in any other study during the next 14 months.
结局指标
主要结局
Number of Hours of Headache
时间窗: 12 weeks
Number of Days With 4 or More Hours of Headache
时间窗: 12 Weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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