A Study to Evaluate White Matter Hyperintensities in Migraine

Mayo Clinic

Status: Active, not recruiting

Conditions: Multiple Sclerosis; Migraine; Small Vessel Ischemic Disease

Treatments: Diagnostic Test: Brain Neuroimaging

Study type: Interventional

Funder types: Other

Identifiers

NCT05112289

21-006203

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: Female

Ages: 20 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Migraine cohort

Other group

Description:

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

Treatment:

Diagnostic Test: Brain Neuroimaging

Small vessel ischemic (SVI) disease cohort

Other group

Description:

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

Treatment:

Diagnostic Test: Brain Neuroimaging

Multiple sclerosis (MS) cohort

Other group

Description:

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

Treatment:

Diagnostic Test: Brain Neuroimaging