Measuring Brain Health Using Low-Field Portable MRI

NCT06533631 | Completed FDA Device

• 2 other identifiers: 20000378361R21NS138995-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

White Matter Hyperintensity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• WMH lesion load (in mm3)

  2 hours

Study Arms (1)

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).

Device: Portable low-field MRI (pMRI); Device: 3T MRI

Interventions

3T MRI DEVICE

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

pMRI and 3T MRI

Portable low-field MRI (pMRI) DEVICE

Participants will receive a pMRI during the study visit.

pMRI and 3T MRI

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

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

New Haven, Connecticut, 06520, United States

Location

Study Officials

• Adam H de Havenon, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 1, 2024
• Study Start: February 5, 2025
• Primary Completion: May 29, 2026
• Study Completion: May 29, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)