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OpenTrials
Active, Not Recruiting

NCT Number: NCT05112289

A Study to Evaluate White Matter Hyperintensities in Migraine

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Migraine Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Headache Disorders Headache Disorders, Primary Immune System Diseases Migraine Disorders Multiple Sclerosis Nervous System Diseases Small Vessel Ischemic Disease

Age range

20 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brain Neuroimaging

Diagnostic Test

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.

Primary outcomes

  1. WMH imaging disease parameters

    Time frame: 3 months

    Radiological MRI assessment of WMH in migraine

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2021
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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