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

NCT ID: NCT02202486

Last Updated: 2014-07-29

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Migraine With Aura Migraine Without Aura Chronic Migraine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Migraine with aura

Brain MRI

Brain MRI

Intervention Type OTHER

Brain MRI with gadolinium contrast

Migraine without aura

Brain MRI

Brain MRI

Intervention Type OTHER

Brain MRI with gadolinium contrast

Chronic migraine

Brain MRI

Brain MRI

Intervention Type OTHER

Brain MRI with gadolinium contrast

Interventions

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Brain MRI

Brain MRI with gadolinium contrast

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Faisal Mohammad Amin

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Faisal M Amin, MD

Role: CONTACT

+4538633066

Facility Contacts

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Faisal M Amin, MD

Role: primary

+4538633066

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.

Reference Type DERIVED
PMID: 34418951 (View on PubMed)

Other Identifiers

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H-3-2012-073

Identifier Type: -

Identifier Source: org_study_id

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