A Study to Evaluate White Matter Hyperintensities in Migraine

Not Applicable

Active, not recruiting

• Conditions: Small Vessel Ischemic Disease; Migraine; Multiple Sclerosis
• Interventions: Diagnostic Test: Brain Neuroimaging

• Registration Number: NCT05112289
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-16
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-08
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Small vessel ischemic (SVI) disease cohort	Brain Neuroimaging	Women diagnosed with SVI disease and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging.
Migraine cohort	Brain Neuroimaging	Women with migraine and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging.
Multiple sclerosis (MS) cohort	Brain Neuroimaging	Women diagnosed with MS and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging.

Primary Outcome Measures

Name	Time	Method
WMH imaging disease parameters	3 months	Radiological MRI assessment of WMH in migraine

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Phoenix, Arizona, United States