NCT00205829已完成1 期
Bion for Occipital Nerve Stimulation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Demonstrate acceptable rate of adverse events.
研究概览
简要总结
This is a prospective, single-centre, cross-over study designed to evaluate the safety and efficacy of using the bion, an implantable medical device, for the treatment of chronic headaches. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study. Each trial subject will serve as his/her own control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 chronic migraine or primary chronic daily headache
- •Have headaches characterized by pain
- •Be 18 years of age or older;
- •Be willing and able to follow all study-related procedures during course of study;
- •Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventive classes.
排除标准
- •Have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days;
- •Have previously undergone destructive ganglionectomy
- •Have had a previous surgery in the intended implant area;
- •Have Arnold-Chiari malformation;
- •Have participated within the last 30 days or plan to participate during this study in another device or drug trial;
- •Be pregnant or planning on becoming pregnant during the study period;
- •Have an implanted electrical device (e.g., pacemaker, spinal cord stimulator) that may interfere with this therapy;
- •Demonstrate significant psychological signs, substance abuse symptoms, or behavioral problems on examination and/or history that, in the investigator's judgment, render them inappropriate for the study;
- •Currently require, or be likely to require, diathermy;
- •Have other medical conditions that the investigator believes would confound the study.
结局指标
主要结局
Demonstrate acceptable rate of adverse events.
时间窗: Throughout the Study
The primary efficacy measure is a significant reduction in either headache frequency or severity
时间窗: 4 months Post-Activation Visit
次要结局
未报告次要终点
研究者
研究点 (2)
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