A Study to Evaluate White Matter Hyperintensities in Migraine

September 3, 2025 updated by: Catherine (Cat) Chong, Mayo Clinic

White Matter Hyperintensities in Migraine: A Multi-modal Imaging Project to Classify Disease Pathology

The purpose of this research is to better understand brain white matter hyperintensities (WMH) in women with migraines

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona

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

20 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria - Migraine (N=20):

  • Female only.
  • Ages 20-45 years.
  • Presence of WMH on MRI.

Exclusion Criteria:

  • History of SVI and/or history of MS or other neurological disease other than migraine.
  • History of cancer or organ transplantation.
  • Contraindication to MRI.
  • Pregnancy.
  • History of abnormal brain MRI other than WMH.
  • Subjects not willing to comply with the study procedures will be removed from the study.

Inclusion Criteria - SVI disease (n=10):

  • Female only
  • Ages > 60 years.
  • Presence of WMH on MRI.

Exclusion Criteria:

  • History of migraine and/or history of MS or other neurological disease other than SVI.
  • History of cancer or organ transplantation.
  • History of abnormal brain MRI other than WMH.
  • Pregnancy.
  • History of abnormal brain MRI other than WMH.
  • Subjects not willing to comply with the study procedures will be removed from the study.

Inclusion Criteria - MS (n=10):

  • Female only.
  • Ages 20-45.
  • Presence of WMH on MRI.

Exclusion Criteria:

  • History of migraine and/or history of SVI or other neurological disease other than MS.
  • History of cancer or organ transplantation.
  • History of abnormal brain MRI other than WMH.
  • Pregnancy.
  • History of abnormal brain MRI other than WMH.
  • Subjects not willing to comply with the study procedures will be removed from the study.

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Migraine cohort
Women with migraine and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging.
Diagnostic test: Brain Neuroimaging
Non-invasive magnetic resonance imaging sequences will investigate metabolic signatures unique to migraine WMH. Imaging data will be used for development of artificial intelligence (AI) algorithms to classify the cause of WMHs.
Other: Small vessel ischemic (SVI) disease cohort
Women diagnosed with SVI disease and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging.
Diagnostic test: Brain Neuroimaging
Non-invasive magnetic resonance imaging sequences will investigate metabolic signatures unique to migraine WMH. Imaging data will be used for development of artificial intelligence (AI) algorithms to classify the cause of WMHs.
Other: Multiple sclerosis (MS) cohort
Women diagnosed with MS and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging.
Diagnostic test: Brain Neuroimaging
Non-invasive magnetic resonance imaging sequences will investigate metabolic signatures unique to migraine WMH. Imaging data will be used for development of artificial intelligence (AI) algorithms to classify the cause of WMHs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WMH imaging disease parameters
Time Frame: 3 months
Radiological MRI assessment of WMH in migraine
3 months

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Catherine Chong, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

August 16, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

November 5, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-006203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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