White Matter HyperintensityMR SCREENNCT06533631
Measuring Brain Health Using Low-Field Portable MRI
An observational study of White Matter Hyperintensity, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- White Matter Hyperintensity
- What is being tested?
- Portable low-field MRI (pMRI) and 3T MRI
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2025to 29 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 1. History of stroke
- History of dementia or other cognitive impairment
- Pacemaker or other MRI contraindications according to the American College of Radiology guidelines
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Magnetic Resonance Research Center (MRRC) at The Analyn Center (TAC)
New Haven, Connecticut, 06520
About this study
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.
Read the 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
- Being tested
- Portable low-field MRI (pMRI), 3T MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable low-field MRI (pMRI)Device
Participants will receive a pMRI during the study visit.
3T MRIDevice
Gold standard MRI for WMH. Participants will receive a 3T MRI during the study visit.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Portable low-field MRI (pMRI); Device: 3T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (1)
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start5 Feb 2025
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Matter HyperintensityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Adam H de Havenon, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533631
- Sponsor's protocol ID
- 2000037836
- Other IDs
- 1R21NS138995-01
- Acronym
- MR SCREEN
- Status last verified
- Jun 2026
- First submitted
- 19 Jul 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Brain Health Using Low-Field Portable MRI
- ClinicalTrials.gov ID
- NCT06533631
- Acronym / sponsor ID
- MR SCREEN / 2000037836
- Conditions
- White Matter Hyperintensity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pMRI and 3T MRI | – | Device: Portable low-field MRI (pMRI), Device: 3T MRIParticipants 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- One vascular risk factor, from the following:
Key exclusion criteria (3 listed)
- 1. History of stroke
- History of dementia or other cognitive impairment
- Pacemaker or other MRI contraindications according to the American College of Radiology guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable low-field MRI (pMRI)Participants will receive a pMRI during the study visit. | Device | pMRI and 3T MRI |
| 3T MRIGold standard MRI for WMH. Participants will receive a 3T MRI during the study visit. | Device | pMRI and 3T MRI |
Primary outcome
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.
1 secondary outcome
WMH lesion load (in mm3)
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam H de Havenon, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of White Matter Hyperintensity, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WMH graded on a low-field WMH scale (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.