Clinical trial NCT02202486: Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI
Official title: Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine With Aura
Migraine Without Aura
Chronic Migraine
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Migraine patients.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood-brain barrier alteration during migraine attacks
timeFrame: Up to 1 year
measure: Cerebral blood flow alteration during migraine attacks
timeFrame: Up to 1 year
measure: Resting-state functional brain connectivity alteration during migraine attacks
timeFrame: Up to 1 year
measure: Voxel-based morphometry alteration during migraine attacks
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center, Glostrup Hospital
state: Copenhagen
Study officials:
affiliation: Danish Headache Center, Glostrup Hospital
name: Faisal M Amin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.