NCT06203626 Ultra-Low Field (ULF) Point-of-Care (POC) MRI System for Brain Morphology and Pathology
| NCT ID | NCT06203626 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Condition | Nervous System Diseases (C10 Unique ID D009422) |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-03-26 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-03-26 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* 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.
Contact & Investigator
Silvina G Horovitz, Ph.D.
PRINCIPAL INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Frequently Asked Questions
Who can join the NCT06203626 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 99 Years, studying Nervous System Diseases (C10 Unique ID D009422). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06203626 currently recruiting?
Yes, NCT06203626 is actively recruiting participants. Contact the research team at zhangr@ninds.nih.gov for enrollment information.
Where is the NCT06203626 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06203626 clinical trial?
NCT06203626 is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). The principal investigator is Silvina G Horovitz, Ph.D. at National Institute of Neurological Disorders and Stroke (NINDS). The trial plans to enroll 200 participants.