Nervous System Diseases (C10 Unique ID D009422)NCT06203626
Ultra-Low Field (ULF) Point-of-Care (POC) MRI System for Brain Morphology and Pathology
An observational study of Nervous System Diseases (C10 Unique ID D009422), run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Nervous System Diseases (C10 Unique ID D009422)
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy volunteers, Patients with previously identified brain anomalies, Patients with known or suspected neurological or neuro-oncological disorders, Stroke patients.
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Ultra-Low Field (ULF) Point Of Care (POC) MRI System for Study Brain Morphology and Pathology
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.
Read more
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.
Read the detailed description
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.
- Keywords
- MRI, Brain, Morphometry, ultra-low field MRI, Lesion
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| participant | we will collect an ULF-MRI from all participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ULF-MRI sensitivity to detect presence of pathology
ULF-MRI sensitivity to detect presence of pathology in comparison to the standard field MRI measured in 100 cases. A study will be considered to have a positive finding if the clinical report from the MRI brain collected at standard field has an observation.
Measured: Visit 1 and optional visit two within 180 days.
Technical development
Optimization of acquisition parameters, reproducibility, and training of personnel.
Measured: Visit 1 and optional repeated visits through the life of the protocol.
Secondary outcomes (1)
Social determinants of health among participants
Characterizing the distribution of participants in our neuroimaging study.
Measured: Visit 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start26 Mar 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System Diseases (C10 Unique ID D009422)Studies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Silvina G Horovitz, Ph.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203626
- Sponsor's protocol ID
- 10001719
- Other IDs
- 001719-N
- Status last verified
- 30 Sep 2026
- First submitted
- 10 Jan 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ULF MRI images with collaborators; ULF-MRI, standard MRI, other data upon tech transfer agreement; IPD that is required for publications.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-Low Field (ULF) Point Of Care (POC) MRI System for Study Brain Morphology and Pathology
- ClinicalTrials.gov ID
- NCT06203626
- Acronym / sponsor ID
- 10001719
- Keywords
- MRI, Brain, Morphometry, ultra-low field MRI, Lesion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jan 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participant | – | –we will collect an ULF-MRI from all participants. |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers, Patients with previously identified brain anomalies, Patients with known or suspected neurological or neuro-oncological disorders, Stroke patients.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ULF-MRI sensitivity to detect presence of pathology
Time frame: Visit 1 and optional visit two within 180 days.
ULF-MRI sensitivity to detect presence of pathology in comparison to the standard field MRI measured in 100 cases. A study will be considered to have a positive finding if the clinical report from the MRI brain collected at standard field has an observation.
Technical development
Time frame: Visit 1 and optional repeated visits through the life of the protocol.
Optimization of acquisition parameters, reproducibility, and training of personnel.
1 secondary outcome
Social determinants of health among participants
Time frame: Visit 1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. ULF MRI images with collaborators; ULF-MRI, standard MRI, other data upon tech transfer agreement; IPD that is required for publications.
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.
Silvina G Horovitz, Ph.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Nervous System Diseases (C10 Unique ID D009422), run by National Institute of Neurological Disorders and Stroke (NINDS) 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 9 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: looking for participants now, as of the sponsor's last update on 2 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruli Zhang ((301) 435-6028, zhangr@ninds.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ULF-MRI sensitivity to detect presence of pathology (time frame: Visit 1 and optional visit two within 180 days.). The study lists 2 primary outcomes in all. 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 2 Oct 2026.