A Study to Evaluate White Matter Hyperintensities in Migraine

Not Applicable

Active, not recruiting

• Conditions: Small Vessel Ischemic Disease; Migraine; Multiple Sclerosis

• 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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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