The MONARCH (Multicenter Occipital Neuralgia and Cervicogenic Headache) Case Series Study: Treatment of Head Pain With the SPRINT® Peripheral Nerve Stimulation (PNS) System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 20
- 主要终点
- Reduction in average pain and/or reduction in pain interference.
研究概览
简要总结
The purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves at the top of the neck. This study will use a device called the SPRINT® PNS System. PNS stands for peripheral nerve stimulation (PNS). This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Diagnosed cervicogenic headache (CGH) or occipital neuralgia (ON)
排除标准
- •Prior cervical or cranial occipital surgery
- •Implanted electronic device (dependent on implant's intended treatment, location, and electrical current pathway)
研究组 & 干预措施
Peripheral Nerve Stimulation
All study subjects will have up to 2 leads placed in the back of their neck, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.
干预措施: SPRINT Peripheral Nerve Stimulation (PNS) System (Device)
结局指标
主要结局
Reduction in average pain and/or reduction in pain interference.
时间窗: Up to 8-weeks after Start of Therapy (SOT)
Average pain is measured using question 5 from the Brief Pain Inventory-Short Form (BPI-5) and pain interference is measured using question 9 from the Brief Pain Inventory-Short Form (BPI-9). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. BPI-9 is a scale of 0 to 10 where 0 represents no interference and 10 represents complete interference.
Study-Related Adverse Events (AEs)
时间窗: 24-months post-SOT
Occurrence and type of study-related AEs
次要结局
- Reduction in average pain intensity(Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT)
- Reduction in pain medication usage(Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT)
- Reduction in pain interference(Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT)