NCT02047695

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

4.2 years

First QC Date

January 26, 2014

Last Update Submit

April 3, 2017

Conditions

Migraine With Aura

Keywords

migraine with auramigrainecase-control studymagnetic resonance imagingbrain diseases

Outcome Measures

Primary Outcomes (1)

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

    At time of MRI

Secondary Outcomes (1)

  • Evidence of other structural and functional changes in brain

    At time of MRI

Study Arms (1)

Migraine with aura

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

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Selected from a population-based twin registry

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine with AuraMigraine DisordersBrain Diseases

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • David Gaist, MD, PhD

    Department of Neurology, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, consultant

Study Record Dates

First Submitted

January 26, 2014

First Posted

January 28, 2014

Study Start

February 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2017

Last Updated

April 4, 2017

Record last verified: 2017-04