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

Chronic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02202486
• Other study ID #: H-3-2012-073
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2014
• Last updated: July 25, 2014
• Start date: September 2012
• Est. completion date: December 2015

Study information

• Verified date: July 2014
• Source: Glostrup University Hospital, Copenhagen
• Contact: Faisal M Amin, MD
• Phone: +4538633066
• Email: faisal.mohammad.amin.01[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders
• Migraine with Aura
• Migraine Without Aura

Intervention

Other:
• Brain MRI
Brain MRI with gadolinium contrast

Locations

Country	Name	City	State
Denmark	Danish Headache Center, Glostrup Hospital	Glostrup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood-brain barrier alteration during migraine attacks		Up to 1 year	No
Primary	Cerebral blood flow alteration during migraine attacks		Up to 1 year	No
Primary	Resting-state functional brain connectivity alteration during migraine attacks		Up to 1 year	No
Primary	Voxel-based morphometry alteration during migraine attacks		Up to 1 year	No