ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- A primary endpoint is not identified for this feasibility study.
研究概览
简要总结
Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month.
Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responsers were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.
详细描述
The therapy under investigation involves a Medtronic neurostimulation device which delivers electrical impulses via insulated lead wires placed under the skin near the occipital nerves at the base of the head.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (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
- •Diagnosis of Chronic Migraine Headache by International Headache Society (IHS) criteria
- •compliance with daily questionnaire
- •headache that has not responded to at least two classes of headache medications
- •stable headache medication regimen
排除标准
- •previous surgical procedures to disrupt the nerves of the neck relating to the headache
- •subjects who may require MRI or Diathermy
研究组 & 干预措施
Group 1
See protocol
干预措施: Occipital Nerve Stimulation (Device)
Group 2
See protocol
干预措施: Occipital Nerve Stimulation (Device)
Group 3
See protocol
干预措施: Occipital Nerve Stimulation (Device)
Group 4
See protocol
干预措施: Occipital Nerve Stimulation (Device)
结局指标
主要结局
A primary endpoint is not identified for this feasibility study.
时间窗: No primary endpoint
次要结局
- Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys.(No secondary endpoint)