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NCT05112289 Clinical Trial

A Study to Evaluate White Matter Hyperintensities in Migraine

Multiple Sclerosis Clinical Trial

Official title:
White Matter Hyperintensities in Migraine: A Multi-modal Imaging Project to Classify Disease Pathology

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05112289
Other study ID # 21-006203
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 16, 2021
Est. completion date August 2024

Study information
Verified date September 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 59 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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.

Locations
Country Name City State
United States Mayo Clinic in Arizona Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary WMH imaging disease parameters Radiological MRI assessment of WMH in migraine 3 months
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