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Women With Migraine With Aura Neuroimaging Study (WOMAN)

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ClinicalTrials.gov Identifier: NCT02047695
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : April 4, 2017
Sponsor:
Collaborators:
Glostrup University Hospital, Copenhagen
Copenhagen University Hospital, Hvidovre
University of Southern Denmark
Information provided by (Responsible Party):
David Gaist, Odense University Hospital

Brief 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

Condition or disease
Migraine With Aura

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Study Type : Observational
Actual Enrollment : 345 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Women With Migraine With Aura Neuroimaging (WOMAN) Study: A Population-based Study of Danish Twins
Study Start Date : February 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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



Primary Outcome Measures :
  1. Evidence of white matter hyperintensities or subclinical ischaemic stroke confirmed by MRI [ Time Frame: At time of MRI ]

Secondary Outcome Measures :
  1. Evidence of other structural and functional changes in brain [ Time Frame: At time of MRI ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Selected from a population-based twin registry
Criteria

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)

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): NCT02047695


Sponsors and Collaborators
Odense University Hospital
Glostrup University Hospital, Copenhagen
Copenhagen University Hospital, Hvidovre
University of Southern Denmark
Investigators
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Principal Investigator: David Gaist, MD, PhD Department of Neurology, Odense University Hospital

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Responsible Party: David Gaist, professor, consultant, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02047695     History of Changes
Other Study ID Numbers: S-20100126
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017

Keywords provided by David Gaist, Odense University Hospital:
migraine with aura
migraine
case-control study
magnetic resonance imaging
brain diseases

Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases