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CompletedNCT02047695WOMANUpdated Apr 4, 2017

Women With Migraine With Aura Neuroimaging Study

An observational study in Migraine With Aura, sponsored by Odense University Hospital. Completed. Open to female participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-04-04.

Sponsored by Odense University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
345
Ages
30 Years to 60 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Migraine With Aura

Keywords

  • migraine with aura
  • migraine
  • case-control study
  • magnetic resonance imaging
  • brain diseases
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 345 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Selected from a population-based twin registry

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

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)
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
345 participants (actual)
Patient registry
No

Groups and cohorts

  • Migraine with aura

    Participants with migraine with aura (cases), their co-twins, and unrelated migraine-free twins (controls)

06

What researchers measure

Primary outcomes

  1. Evidence of white matter hyperintensities or subclinical ischaemic stroke confirmed by MRI

    Time frame: At time of MRI

Secondary outcomes

  1. Evidence of other structural and functional changes in brain

    Time frame: At time of MRI

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02047695
Lead sponsor
Odense University Hospital
Collaborators
Glostrup University Hospital, Copenhagen, Copenhagen University Hospital, Hvidovre, University of Southern Denmark
Responsible party
David Gaist (professor, consultant, Odense University Hospital) — Principal investigator
First posted
Jan 28, 2014
Start date
Feb 2011
Primary completion
Apr 2015
Completion
Apr 2017
Last update
Apr 4, 2017

Study contacts

David Gaist, MD, PhD
principal investigator · Department of Neurology, Odense University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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