Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI
NCT ID: NCT02202486
Last Updated: 2014-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2012-09-30
2015-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Migraine with aura
Brain MRI
Brain MRI
Brain MRI with gadolinium contrast
Migraine without aura
Brain MRI
Brain MRI
Brain MRI with gadolinium contrast
Chronic migraine
Brain MRI
Brain MRI
Brain MRI with gadolinium contrast
Interventions
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Brain MRI
Brain MRI with gadolinium contrast
Eligibility Criteria
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Inclusion Criteria
* written informed consent.
* use of anticonceptive method by women in childbearing age.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Glostrup University Hospital, Copenhagen
OTHER
Responsible Party
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Faisal Mohammad Amin
medical doctor
Principal Investigators
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Faisal M Amin, MD
Role: PRINCIPAL_INVESTIGATOR
Danish Headache Center, Glostrup Hospital
Locations
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Danish Headache Center, Glostrup Hospital
Glostrup Municipality, Copenhagen, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Amin FM, De Icco R, Al-Karagholi MA, Raghava JM, Wolfram F, Larsson HBW, Ashina M. Investigation of cortical thickness and volume during spontaneous attacks of migraine without aura: a 3-Tesla MRI study. J Headache Pain. 2021 Aug 21;22(1):98. doi: 10.1186/s10194-021-01312-9.
Other Identifiers
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H-3-2012-073
Identifier Type: -
Identifier Source: org_study_id
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