CClinicalTrials.gg
Active, not recruitingNCT05112289Updated Sep 24, 2026

A Study to Evaluate White Matter Hyperintensities in Migraine

An interventional study of Brain Neuroimaging in Migraine, Small Vessel Ischemic Disease and Multiple Sclerosis, sponsored by Mayo Clinic. Active, not recruiting at 1 site in United States. Open to female participants aged 20 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
20 Years to 59 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Migraine
  • Small Vessel Ischemic Disease
  • Multiple Sclerosis
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 59 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Diagnostic testBrain 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.

06

What researchers measure

Primary outcomes

  1. WMH imaging disease parameters

    Radiological MRI assessment of WMH in migraine

    Time frame: 3 months

07

Study locations

1 site
  • Mayo Clinic in Arizona
    Phoenix, Arizona 85054, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05112289
Lead sponsor
Mayo Clinic
Responsible party
Catherine (Cat) Chong (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Nov 8, 2021
Start date
Aug 16, 2021
Primary completion
Sep 3, 2028 (estimated)
Completion
Sep 3, 2028 (estimated)
Last update
Sep 24, 2026

Study contacts

Catherine Chong, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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