Recruiting

Ultra-Low Field MRI

Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Code:

NCT06203626

Conditions

Nervous System Diseases (C10 Unique ID D009422)

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Background:

Magnetic resonance imaging (MRI) is a tool for getting pictures of the tissues and organs inside the body. MRI can help diagnose many injuries and diseases. But not all patients are equally likely to receive MRIs. Factors such as race or ethnicity, distance to imaging centers, mobility, and a lower income can limit some people s access to MRIs. A new ultra-low field (ULF) type of MRI, which can be used on a vehicle, may help take imaging scans to more people. But researchers need to know that UFL-MRI works just as well as standard MRIs.

Objective:

To learn whether UFL-MRI is as good as standard MRI at detecting neurological disorders.

Eligibility:

People aged 3 years or older who have or show symptoms of neurological disease (such as stroke, cancer, or epilepsy). Healthy adults are also needed.

Design:

Participants will have 1 or 2 study visits.

Adult participants will have a physical exam. They will receive two MRI exams:

  • Standard MRI. They will lie still on a narrow bed that will move into a large tube. They will wear earplugs to muffle the sounds.
  • ULF-MRI. They will lie on a stretcher, and only their head will be inside a smaller tube. The noises will be quieter. They will wear earplugs to muffle the sounds.

Some adults may receive a contrast agent given through a small tube attached to a needle in the arm. The contrast agent helps the researchers see differences in the body more clearly. This may be done during 1 or both MRIs.

Children will have only 1 ULF-MRI.

Some participants may be invited to have additional visits for up to 6 months.

Conditions

Nervous System Diseases (C10 Unique ID D009422)

Study ID

NCT06203626

Start date

Mar 26, 2024

Status verified date

Jul 31, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

participant

we will collect an ULF-MRI from all participants.

Primary outcome measure

  • ULF-MRI sensitivity to detect presence of pathology [ Time Frame: Visit 1 and optional visit two within 180 days. ]
  • Technical development [ Time Frame: Visit 1 and optional repeated visits through the life of the protocol. ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Last update posted

Aug 7, 2026

Last verified

Jul 31, 2026

Keywords

  • MRI
  • Brain
  • Morphometry
  • ultra-low field MRI
  • Lesion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Neurological Disorders and Stroke (NINDS) on 2026-08-07.