NCT00286078已完成不适用
Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 30
- 主要终点
- Frequency of Adverse Event
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of an implantable device for difficult 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
- Parallel
- 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 for 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 migraine after age 50;
- •Have a significant psychiatric disorder;
- •Have previously been treated with occipital nerve stimulation;
- •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 radio frequency procedure currently in effect;
- •Have a condition currently requiring or likely to require the use of MRI or diathermy;
- •Have an active implantable device;
- •Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study.
研究组 & 干预措施
Control
Sham Comparator
Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
干预措施: Precision (Device)
Treatment
Experimental
Active occipital nerve stimulation (stimulation on)
干预措施: Precision (Device)
结局指标
主要结局
Frequency of Adverse Event
时间窗: 26 weeks
Cumulative frequency of adverse events from randomization to 26 weeks
Migraine Frequency at 12 Weeks
时间窗: Baseline and 12 weeks
Change from baseline in migraine days/month at 12 weeks
次要结局
未报告次要终点
研究者
研究点 (30)
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