NCT05112289

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress95%
Aug 2021Aug 2026

Study Start

First participant enrolled

August 16, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

October 12, 2021

Last Update Submit

September 3, 2025

Conditions

MigraineSmall Vessel Ischemic DiseaseMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • WMH imaging disease parameters

    Radiological MRI assessment of WMH in migraine

    3 months

Study Arms (3)

Migraine cohort

OTHER

Women with migraine and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging.

Diagnostic Test: Brain Neuroimaging

Small vessel ischemic (SVI) disease cohort

OTHER

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

Multiple sclerosis (MS) cohort

OTHER

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

Brain NeuroimagingDIAGNOSTIC_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.

Migraine cohortMultiple sclerosis (MS) cohortSmall vessel ischemic (SVI) disease cohort

Eligibility Criteria

Age20 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.
  • Female only
  • Ages \> 60 years.
  • Presence of WMH on MRI.
  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Migraine DisordersMultiple Sclerosis

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Catherine Chong, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2021

First Posted

November 8, 2021

Study Start

August 16, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

September 5, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)