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

• Conditions: Migraine With Aura; Migraine Without Aura; Chronic Migraine
• Interventions: Other: Brain MRI

• Registration Number: NCT02202486
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-09
• Status Verified: 2014-07
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-25
• Last Update Submitted: 2014-07-25
• Study First Posted: 2014-07-29
• Last Update Posted: 2014-07-29
• Primary Completion: 2015-07
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Migraine with aura	Brain MRI	Brain MRI
Migraine without aura	Brain MRI	Brain MRI
Chronic migraine	Brain MRI	Brain MRI

Primary Outcome Measures

Name	Time	Method
Blood-brain barrier alteration during migraine attacks	Up to 1 year
Cerebral blood flow alteration during migraine attacks	Up to 1 year
Resting-state functional brain connectivity alteration during migraine attacks	Up to 1 year
Voxel-based morphometry alteration during migraine attacks	Up to 1 year

Trial Locations

Locations (1)

Danish Headache Center, Glostrup Hospital; 🇩🇰 Glostrup, Copenhagen, Denmark