Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02202486
Enrollment
600
Registered
2014-07-29
Start date
2012-09-30
Completion date
2015-12-31
Last updated
2014-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Migraine, Migraine With Aura, Migraine Without Aura

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.

Interventions

OTHERBrain MRI

Brain MRI with gadolinium contrast

Sponsors

Glostrup University Hospital, Copenhagen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Blood-brain barrier alteration during migraine attacksUp to 1 year
Cerebral blood flow alteration during migraine attacksUp to 1 year
Resting-state functional brain connectivity alteration during migraine attacksUp to 1 year
Voxel-based morphometry alteration during migraine attacksUp to 1 year

Countries

Denmark

Contacts

Primary ContactFaisal M Amin, MD
faisal.mohammad.amin.01@regionh.dk+4538633066

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026