Ultra-Low Field (ULF) Point-of-Care (POC) MRI System for Brain Morphology and Pathology

Study Description:

Within the long-term goal of establishing a mobile research unit, this protocol aims at better understanding the utility and applicability of ULF MRI to deliver accessible neuroimages that could provide an opportunity for increasing participation in research, for early therapeutic intervention, and for potentially improvement of standard of care. For this purpose, we will invite healthy volunteers and populations with neurological presentations, mostly those enrolled in NIH studies collecting standard brain MRI, to participate in this protocol for ULF-MRI data collection. We will evaluate ULF MRI images in comparison to the standard field images. This analysis will aid at defining the type of research we can do with the ULF as a stand-alone technique and provide preliminary data for future research.

Based on the different clinical presentations, ancillary measures, such as cognitive, motor, and fatigue scales, optical coherence tomography, fundus, or blood samples, among others, might be collected to provide guidance for future studies.

Objectives:

Primary Objectives:

• Measure the ULF-MRI sensitivity to detect presence of pathology using the standard field MRI as the gold standard.
• To provide a framework for technical development.

Secondary Objective:

Describe participants social determinants of health.

Endpoints:

Primary Endpoint: ULF-MRI sensitivity to detect presence of pathology in comparison to the standard field MRI measured in 100 cases.

Secondary Endpoints: Descriptive participation.

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Volunteer of any gender, 3 years of age and older.
• Adult participant: must be capable of understanding the procedures and requirements of this study and be able and willing to sign an informed consent document.
• Minor participant: Must have a parent or guardian capable of understanding the procedures and requirements of this study who are willing to sign an informed parental consent document, and where feasible, the minor age 7 and older provides assent.
• Either:

• Adult in good general health as evidenced by medical history or
• Diagnosed with a stroke, a neurological or neuro-oncological disease, or
• Exhibiting symptoms suggestive of neurological or neuro-oncological disease.

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

• Unable to undergo MRI study based on screening (e.g., presence of non-MRI compatible objects).
• Pregnancy or lactation, if contrast agent is required.