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Completed

NCT Number: NCT06533631

Measuring Brain Health Using Low-Field Portable MRI

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • One vascular risk factor, from the following:
  • Hypertension (defined as taking an antihypertensive medication)
  • Hyperlipidemia (defined as taking a statin or PCSK9 inhibitor)
  • 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

Treatment and study plan

Portable low-field MRI (pMRI)

Device

Participants will receive a pMRI during the study visit.

3T MRI

Device

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

Primary outcomes

  1. WMH graded on a low-field WMH scale

    Time frame: 2 hours

    Each pMRI scan will be evaluated by two readers experienced in the adjudication of WMH and the high-field 3T MRI will be adjudicated by a board certified neuroradiologist. WMH will be graded on a low-field WMH scale as minimal, moderate, or severe. The low-field WMH scale will be derived by an expert panel consisting of the study investigators and two more neurologists, a neuroradiologist, and neuropsychologist. Investigators will employ the Delphi method to harness the collective expertise of this panel in developing the novel grading scale.

Secondary outcomes

  1. WMH lesion load (in mm3)

    Time frame: 2 hours

    WMH lesion load will be assessed both global and per white matter region of interest (ROI). These ROIs are defined by FreeSurfer, which maps cortical parcels into corresponding WM segments using geodesic distances. Using the high-field MRI as ground truth, investigators will use two metrics to evaluate the WMH in pMRI. The first, and main validation criterion, is the Spearman correlation coefficient between lesion loads (both global and per ROI) estimated from pMRI (by the neural network) and from high-field MRI (obtained via manual delineation). And second, the Dice score between the predicted WMH mask in pMRI and the corresponding ground truth from the high-field MRI.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Acronym: MR SCREEN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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