Overview

This trial is active, not recruiting.

Condition migraine with aura
Sponsor Odense University Hospital
Collaborator Glostrup University Hospital, Copenhagen
Start date February 2011
End date April 2015
Trial size 330 participants
Trial identifier NCT02047695, S-20100126

Summary

The purpose of this study is to investigate whether a particular form of migraine, migraine with aura, is associated with structural changes in the brain

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm
Participants with migraine with aura (cases), their co-twins, and unrelated migraine-free twins (controls)

Primary Outcomes

Measure
Evidence of white matter hyperintensities or subclinical ischaemic stroke confirmed by MRI
time frame: At time of MRI

Secondary Outcomes

Measure
Evidence of other structural and functional changes in brain
time frame: At time of MRI

Eligibility Criteria

Female participants from 30 years up to 60 years old.

Inclusion Criteria: - female - case (migraine with aura), co-twin to case, or control (migraine-free) - residency in Denmark - no severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders Exclusion Criteria: - male - residency outside Denmark - registered in Civil Registry as not to be contacted by researchers - severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders - mobile metal parts or other contraindication for MRI - weight of 130+ kilograms - pregnancy - subjects that wished not to be informed about abnormal findings on MRI - chronic tension-type headache, medication overuse headache, or cluster headache (diagnosed through physician interview) - frequent tension-type headache (control group only, self-reported or diagnosed through physician interview)

Additional Information

Official title Women With Migraine With Aura Neuroimaging (WOMAN) Study: A Population-based Study of Danish Twins
Principal investigator David Gaist, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Odense University Hospital.