NCT01896167已完成不适用
Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Headache and aura
研究概览
简要总结
In this study the investigators will investigate the following hypothesis
- that hypoxia induce migraine headache and migraine aura
- the aura phase is associated with a spreading reduction in cerebral blood flow
- the migraine headache is associated with dilatation of intra- and extracerebral arteries
- the migraine headache is associated with changes in brain metabolism
- the pre-ictal stage of a migraine attack with aura is associated with specific patterns in neural activity.
详细描述
To investigate migraine with aura symptoms during and after hypoxia.
With magnetic resonance imaging the investigators will investigate changes in
- regional cerebral blood flow (rCBF)
- resting state functional connectivity
- circumference of the middle cerebral artery(MCA), internal carotic artery, superficial temporal artery, medial meningeal artery, external carotic artery
- brain metabolism
And compare these changes with a aged match healthy control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Migraine with aura patients and Helthy volunteers as controls:
- •Aged 18-40
- •50-100 kg
排除标准
- •Tension type headache more than 5 days/month
- •Other primary headaches
- •Daily medication except contraceptives
- •Drug taken within 4 times the halflife for the specific drug except contraceptives
- •Pregnant or lactating women
- •Headache or migraine attack within the last 48 hours before start of trial
- •Hypertension
- •Hypotension
- •Respiratory or cardiac disease
- •Extra exclusion Criteria for healthy volunteers:
- •migraine at present or earlier in life
- •parents, sibling or children who suffer or have suffered from migraine
结局指标
主要结局
Headache and aura
时间窗: 24 h
Comparison between hypoxia and placebo (atmospheric air)
次要结局
- BOLD response in visual cortex(Baseline, 170 min and 220 min)
- Brain metabolism(Baseline, 180 min and 230 min post hypoxia)
- artery circumference(Baseline, 120 and 200 min)
- Cerebral blood flow(Baseline, 120 and 200 min)
研究者
Nanna Arngrim
MD, medical doctors
Danish Headache Center
研究点 (2)
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