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

July 25, 2014 updated by: Faisal Mohammad Amin, Glostrup University Hospital, Copenhagen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Migraine patients.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood-brain barrier alteration during migraine attacks
Time Frame: Up to 1 year
Up to 1 year
Cerebral blood flow alteration during migraine attacks
Time Frame: Up to 1 year
Up to 1 year
Resting-state functional brain connectivity alteration during migraine attacks
Time Frame: Up to 1 year
Up to 1 year
Voxel-based morphometry alteration during migraine attacks
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Faisal M Amin, MD, Danish Headache Center, Glostrup Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 25, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 25, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2012-073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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