Women With Migraine With Aura Neuroimaging Study (WOMAN)

April 3, 2017 updated by: David Gaist, Odense University Hospital

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

345

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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Selected from a population-based twin registry

Description

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)

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of other structural and functional changes in brain
Time Frame: At time of MRI
At time of MRI

Collaborators and Investigators

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

Sponsor

Odense University Hospital

Collaborators

University of Southern Denmark
Glostrup University Hospital, Copenhagen
Copenhagen University Hospital, Hvidovre

Investigators

  • Principal Investigator: David Gaist, MD, PhD, Department of Neurology, Odense University Hospital

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

February 1, 2011

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

January 26, 2014

First Submitted That Met QC Criteria

January 26, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20100126

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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