Middle Meningeal Artery Embolization for Treatment of Chronic Migraine: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 70
- 主要终点
- Migraine Disability Assessment (MIDAS)
研究概览
简要总结
The main goal of this study is to find out how well middle meningeal artery coil embolization works for patients with recurrent chronic migraines that are not resolved with medication.
详细描述
This study seeks to evaluate the therapeutic potential of middle meningeal artery coil embolization as an interventional strategy for patients with recurrent and pharmacoresistant chronic migraine. Middle meningeal artery embolization has recently gained recognition as a safe and effective intervention for the management of chronic subdural hematoma, demonstrating a low complication profile. The procedure achieves therapeutic effect by reducing or occluding arterial flow within the middle meningeal artery, thereby minimizing arterial dilatation and facilitating hematoma resorption over time.
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
- •Patient with diagnosis of migraine with or without aura, chronic migraine, unilateral or bilateral, moderate to severe intensity, 4-72 hours, familiar or sporadic, status migrainosus, primary or secondary
- •Patient who failed pharmacologic treatment (at least 2 failed drugs treatment for more than 3 months) or have considerable side effects
- •Patient with diagnosis of migraine and preference for embolization treatment
- •Clinical follow up of at least 3 months
- •Baseline computed tomography head (CTH) or MR brain which rule out additional intracranial pathology (patient with baseline intracranial pathology other than migraine will be excluded; see the
排除标准
- •section below)
- •Presence of patent middle meningeal artery homolateral to the side of migraine
- •Exclusion Criteria:
- •Previous middle meningeal artery embolization for subdural hematoma
- •Previous craniotomy
- •Patients aged 17 years or younger.
- •Incomplete embolization of middle meningeal artery
- •Patient with baseline CTH or MR brain showing baseline intracranial pathology that can explain migraine
研究组 & 干预措施
Middle Meningeal Artery Embolization
Participants receive middle meningeal artery embolization
干预措施: Middle Meningeal Artery Embolization (Procedure)
结局指标
主要结局
Migraine Disability Assessment (MIDAS)
时间窗: Month 12 Follow Up
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Pain Scale
时间窗: Month 12 Follow Up
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Migraine Disability Assessment (MIDAS)
时间窗: Baseline
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Disability Assessment (MIDAS)
时间窗: 1 Hour Post Procedure
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Disability Assessment (MIDAS)
时间窗: Day 15 Follow Up
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Disability Assessment (MIDAS)
时间窗: Month 3 Follow Up
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Disability Assessment (MIDAS)
时间窗: Month 6 Follow Up
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Pain Scale
时间窗: Baseline
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Migraine Pain Scale
时间窗: 1 Hour Post Procedure
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Migraine Pain Scale
时间窗: Day 15 Follow Up
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Migraine Pain Scale
时间窗: Month 3 Follow Up
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Migraine Pain Scale
时间窗: Month 6 Follow Up
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
次要结局
- Number of Pain Meds Used Post Procedure(Month 12 Follow Up)
- Number of Pain Meds Used Post Procedure(1 Hour Post Procedure)
- Number of Pain Meds Used Post Procedure(6 Hours Post Procedure)
- Number of Pain Meds Used Post Procedure(Day 15 Follow Up)
- Number of Pain Meds Used Post Procedure(Month 3 Follow Up)
- Number of Pain Meds Used Post Procedure(Month 6 Follow Up)