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

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ClinicalTrials.gov Identifier: NCT02202486
Recruitment Status : Unknown
Verified July 2014 by Faisal Mohammad Amin, Glostrup University Hospital, Copenhagen.
Recruitment status was:  Recruiting
First Posted : July 29, 2014
Last Update Posted : July 29, 2014
Sponsor:
Information provided by (Responsible Party):
Faisal Mohammad Amin, Glostrup University Hospital, Copenhagen

Study Description
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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.


Condition or disease Intervention/treatment
Migraine With Aura Migraine Without Aura Chronic Migraine Other: Brain MRI

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 Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI
Study Start Date : September 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Groups and Cohorts
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Group/Cohort Intervention/treatment
Migraine with aura
Brain MRI
 Other: Brain MRI
Brain MRI with gadolinium contrast
Migraine without aura
Brain MRI
 Other: Brain MRI
Brain MRI with gadolinium contrast
Chronic migraine
Brain MRI
 Other: Brain MRI
Brain MRI with gadolinium contrast


Outcome Measures
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Primary Outcome Measures :
  1. Blood-brain barrier alteration during migraine attacks [ Time Frame: Up to 1 year ]
  2. Cerebral blood flow alteration during migraine attacks [ Time Frame: Up to 1 year ]
  3. Resting-state functional brain connectivity alteration during migraine attacks [ Time Frame: Up to 1 year ]
  4. Voxel-based morphometry alteration during migraine attacks [ Time Frame: Up to 1 year ]

Biospecimen Retention:   Samples Without DNA
Creatinine, blood glucose, potassium, haemoglobin, erytrocyte profile

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Migraine patients.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202486


Contacts
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Contact: Faisal M Amin, MD +4538633066 faisal.mohammad.amin.01@regionh.dk

Locations
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Denmark
Danish Headache Center, Glostrup Hospital Recruiting
Glostrup, Copenhagen, Denmark, 2600
Contact: Faisal M Amin, MD    +4538633066    faisal.mohammad.amin.01@regionh.dk   
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
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Principal Investigator: Faisal M Amin, MD Danish Headache Center, Glostrup Hospital
More Information
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Responsible Party: Faisal Mohammad Amin, medical doctor, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT02202486    
Other Study ID Numbers: H-3-2012-073
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Migraine Disorders
Migraine without Aura
Migraine with Aura
Headache Disorders, Primary
 Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases