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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02202486
Other study ID # H-3-2012-073
Secondary ID
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


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
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