Women With Migraine With Aura Neuroimaging Study | NCT02047695

Studies
Women With Migraine With Aura Neuroimaging Study

NCT02047695

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Apr 4, 2017Actual

Enrollment

345Actual

Phase

Not provided

Conditions

Migraine With Aura

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2017Actual

First Submitted Date

Jan 26, 2014

First Submission Date that Met QC Criteria

Jan 26, 2014

First Posted Date

Jan 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2017

Last Update Posted Date

Apr 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Gaist, professor, consultant, Odense University HospitalPrincipal Investigator

Lead Sponsor

Odense University HospitalOTHER

Collaborators

Name	Class
Glostrup University Hospital, Copenhagen	OTHER
Copenhagen University Hospital, Hvidovre	OTHER
University of Southern Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

345Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Migraine with aura		Participants with migraine with aura (cases), their co-twins, and unrelated migraine-free twins (controls)

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Selected from a population-based twin registry

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Gaist, MD, PhD	Department of Neurology, Odense University Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020325	Migraine with Aura
D008881	Migraine Disorders
D001927	Brain Diseases

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided