Measuring Brain Health Using Low-Field Portable MRI

NCT ID: NCT06533631

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2026-11-30

Brief Summary

The purpose of this study is to develop a new grading scale and utilize automated segmentation for measurement of White Matter Hyperintensity (WMH) volume using a low field MRI.

Detailed Description

This study will take place in one visit, if feasible. This visit will take approximately 2 hours. (Alternatively, the visit can be split over two visits if the subject cannot tolerate two consecutive scans. The pMRI and 3T MRI can occur up to one month apart.)

The purpose of this study is to create both a qualitative lowfield WMH scale that can be used widely and a machine learning enabled quantitative measurement of WMH for more sophisticated applications. To ensure the reliability of these WMH measurement systems, participants will receive both a pMRI and high-field 3T MRI at a single study visit for the purpose of comparing WMH measurements against a gold standard (3T MRI). Using the Delphi method, an expert panel of pMRI researchers will develop the low-field WMH grading scale, iteratively refine it, and validate it within this cohort. Parallel to this, advanced machine learning methodologies will be utilized in this cohort, allowing for precise quantification of WMH volume on pMRI.

Conditions

White Matter Hyperintensity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

pMRI and 3T MRI

Participants will receive both a pMRI and high-field 3T MRI at a single study visit for the purpose of comparing WMH measurements against a gold standard (3T MRI).

Portable low-field MRI (pMRI)

Intervention Type: DEVICE

Participants will receive a pMRI during the study visit.

3T MRI

Intervention Type: DEVICE

Gold standard MRI for WMH. Participants will receive a 3T MRI during the study visit.

Interventions

Portable low-field MRI (pMRI)

Participants will receive a pMRI during the study visit.

Intervention Type: DEVICE

3T MRI

Gold standard MRI for WMH. Participants will receive a 3T MRI during the study visit.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• One vascular risk factor, from the following:

1. Hypertension (defined as taking an antihypertensive medication)

2. Hyperlipidemia (defined as taking a statin or PCSK9 inhibitor)

3. Diabetes (defined as taking a medication to prevent hyperglycemia)

Exclusion Criteria

• 1. History of stroke
• History of dementia or other cognitive impairment
• Pacemaker or other MRI contraindications according to the American College of Radiology guidelines

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam H de Havenon, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Magnetic Resonance Research Center (MRRC) at The Analyn Center (TAC)

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Adam H de Havenon, MD

Role: CONTACT

adam.dehavenon@yale.edu

203-785-4085

Other Identifiers

2000037836

Identifier Type: -

Identifier Source: org_study_id

1R21NS138995-01

Identifier Type: NIH

Identifier Source: secondary_id

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