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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21NS138995-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable low-field MRI (pMRI) | Device | Participants will receive a pMRI during the study visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| WMH graded on a low-field WMH scale | 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. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| WMH lesion load (in mm3) | 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. |
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Inclusion Criteria:
One vascular risk factor, from the following:
Exclusion Criteria:
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Participants, age 50+, with risk factors for white matter hyperintensities, including hypertension, hyperlipidemia and diabetes. Patients may be identified through flyers distributed among outpatient clinics at Yale-New Haven Hospital for general neurology, internal medicine, and preventive cardiology.
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| Name | Affiliation | Role |
|---|---|---|
| Adam H de Havenon, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Magnetic Resonance Research Center (MRRC) at The Analyn Center (TAC) | New Haven | Connecticut | 06520 | United States |
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| 3T MRI | Device | Gold standard MRI for WMH. Participants will receive a 3T MRI during the study visit. |
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| 2 hours |