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临床试验/NCT02202486
NCT02202486Unknown不适用

Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI

Glostrup University Hospital, Copenhagen1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
1
主要终点
Resting-state functional brain connectivity alteration during migraine attacks

研究概览

简要总结

Substudy 1 Blood-brain barrier breakdown has been proposed in migraine patients. Our hypothesis that we will test in this study is that the blood-brain barrier breaks down during migraine attacks but not out side attacks using MRI.

Substudy 2 Altered cerebral resting-state functional connectivity networks have been reported in migraine patients outside migraine attacks. What happens during migraine attacks has never been investigated. The hypothesis we will test is that pain related networks are affected during spontaneous attacks using functional MRI.

Substudy 3 Old studies report that cerebral blood flow (CBF) is altered in patients with migraine with aura, but not in those without aura. We hypothesize that CBF is altered regionally during attacks, which we will investigate in this study using arterial spin labeling (ASL).

Substudy 4 Structural changes using voxel-based morphometry (VBM) of the brain have been suggested but never investigated during migraine attacks. Our hypothesis is that pain related structures show altered VBM during spontaneous migraine attacks.

详细描述

Brain MRI during and outside migraine attacks.

Up to 600 patients will be recruited, who will be given a phone number that they can call when they get migraine attacks.

The study will continue until 20 patients with migraine with aura, 20 patients without aura, 20 patients with chronic migraine have completed the study.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of migraine with aura, migraine without aura, or chronic migraine according to the International Headache Society.
  • written informed consent.
  • use of anticonceptive method by women in childbearing age.

排除标准

  • tension type headache more than 5/month during last year.
  • tension type headache on the experimental day.
  • use of antimigraine medication or pain-killer on the experimental day before MRI.
  • pregnant or breastfeeding women.
  • contraindications against MRI.
  • history or clinical sign of cardio- or cerebrovascular disease.
  • untreated severe mental disorder or drug abuse.
  • other diseases or disorders interpreted, by the examining doctor, to interfere with participation in the study.
  • not accepting information about potential accidental finding during experiment.

结局指标

主要结局

Resting-state functional brain connectivity alteration during migraine attacks

时间窗: Up to 1 year

Blood-brain barrier alteration during migraine attacks

时间窗: Up to 1 year

Cerebral blood flow alteration during migraine attacks

时间窗: Up to 1 year

Voxel-based morphometry alteration during migraine attacks

时间窗: Up to 1 year

次要结局

未报告次要终点

研究者

发起方
Glostrup University Hospital, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Faisal Mohammad Amin

medical doctor

Glostrup University Hospital, Copenhagen

研究点 (1)

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