A Study to Evaluate White Matter Hyperintensities in Migraine

NCT ID: NCT05112289

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2026-08-31

Brief Summary

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

Detailed Description

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Conditions

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Migraine Small Vessel Ischemic Disease Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Migraine cohort

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

Group Type OTHER

Brain Neuroimaging

Intervention Type 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.

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.

Group Type OTHER

Brain Neuroimaging

Intervention Type 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.

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.

Group Type OTHER

Brain Neuroimaging

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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


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


* Female only.
* Ages 20-45.
* 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.


* 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.


* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Catherine (Cat) Chong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine Chong, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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21-006203

Identifier Type: -

Identifier Source: org_study_id

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