Women With Migraine With Aura Neuroimaging Study

Migraine With Aura Clinical Trial

— WOMAN  

Official title:

Women With Migraine With Aura Neuroimaging (WOMAN) Study: A Population-based Study of Danish Twins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047695
• Other study ID #: S-20100126
• Status: Completed
• Phase: N/A
• First received: January 26, 2014
• Last updated: April 3, 2017
• Start date: February 2011
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: April 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	Copenhagen University Hospital, Hvidovre, Glostrup University Hospital, Copenhagen, University of Southern Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of white matter hyperintensities or subclinical ischaemic stroke confirmed by MRI		At time of MRI
Secondary	Evidence of other structural and functional changes in brain		At time of MRI