MRI and MRS Brain Scans for Brain Mapping in Healthy Subjects

Recruiting at 1 trial location

Overseen By Christopher Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Mental Health (NIMH)

Disqualifiers: Axis 1 diagnosis, HIV, Neurological illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

300 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: - Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of the human body and evaluate activity in the brain. A particular MRI method called magnetic resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help researchers who are studying new treatments for psychiatric illnesses. Researchers are interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS techniques to view and measure brain chemicals and brain activity. Objectives: - To implement, develop, and optimize brain chemistry imaging techniques using magnetic resonance imaging and magnetic resonance spectroscopy. Eligibility: - Healthy individuals between 18 and 65 years of age. Design: * This study will involve a screening visit and a scanning visit at the National Institutes of Health Clinical Center. * Participants will be screened with a full medical and physical examination, blood and urine tests, and neurological testing. * During the second visit, participants will have an MRI scan of the brain. (Participants who have received an MRI within the past year will not need to have a second one; the images of the previous scan will be used for this study.) All participants will then have an MRS scan using the same scanning equipment....

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy individuals without significant medical conditions, it's possible that certain medications might need to be paused. Please consult with the study coordinators for specific guidance.

What data supports the effectiveness of the treatment Magnetic Resonance Spectroscopic Imaging Techniques?

Research shows that Magnetic Resonance Spectroscopic Imaging (MRSI) can provide detailed images of brain metabolites, which helps in analyzing brain metabolism and potentially diagnosing brain diseases early. Proton Magnetic Resonance Spectroscopy (1H MRS) has been useful in studying neurological and psychiatric disorders, with better results at higher magnetic field strengths. ^{1 2 3 4 5}

Is MRI and MRS brain scanning safe for healthy humans?

MRI and MRS brain scans are generally considered safe for healthy humans, as they are non-invasive techniques widely used in clinical and research settings to evaluate brain metabolism without the use of ionizing radiation. ^{2 5 6 7 8}

How is this brain mapping treatment different from other treatments?

This treatment uses MRI and MRS brain scans to map brain metabolism in healthy subjects, which is unique because it provides non-invasive insights into brain function without the need for drugs or invasive procedures. Unlike standard imaging techniques, MRS can assess metabolic changes, offering a deeper understanding of brain health. ^{3 5 7 9 10}

Research Team

Li An, Ph.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Eligibility Criteria

This trial is for healthy individuals aged 18 to 65 who can consent and lie flat for about two and a half hours. It's not suitable for those with significant lab abnormalities, pregnant or breastfeeding women, people with metallic implants affected by MRI, claustrophobia, HIV positive individuals, substance use disorders, current psychiatric diagnoses or neurological conditions.

Inclusion Criteria

Healthy based on medical history and physical exam

I am between 18 and 65 years old.

Able to give written informed consent

Exclusion Criteria

Metallic foreign bodies that would be affected by the magnetic resonance imaging (MRI) magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan

Pregnant or breastfeeding

NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

MRI and MRS Scanning

Participants undergo MRI and MRS scans to evaluate brain and muscle metabolites

1-2 hours

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects post-scan

1 week

Treatment Details

Interventions

• Magnetic Resonance Spectroscopic Imaging Techniques

Trial Overview The study aims to improve brain imaging techniques using magnetic resonance imaging (MRI) and spectroscopy (MRS). Participants will undergo medical exams followed by an MRI scan of the brain and MRS scans to view and measure brain chemicals.

Participant Groups

Group I: One Arm Experimental Treatment 2 Interventions

Subjects receive the same scan

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials

3,007

Recruited

2,852,000+

Findings from Research

The new phosphorus magnetic resonance spectroscopic imaging (MRSI) technique using flyback readout achieved significant reductions in acquisition time, with up to 10 times faster imaging compared to traditional methods, while maintaining a high signal-to-noise ratio.

In tests on healthy volunteers' calf muscles and brains, the new technique showed no significant differences in metabolite quantification compared to conventional methods, confirming its reliability for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phosphorus magnetic resonance spectroscopic imaging using flyback echo planar readout trajectories. Santos-Díaz, A., Obruchkov, SI., Schulte, RF., et al.[2018]

A new method for (31)P MR spectroscopic imaging (MRSI) was developed that allows for faster and more accurate B1(+) mapping, reducing measurement time to one-sixth of the normal duration, which enhances the efficiency of the imaging process.

In vivo tests on healthy volunteers demonstrated that this method improved the homogeneity of metabolite maps in calf muscle and brain, indicating its potential for better quantification in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flip-angle mapping of 31P coils by steady-state MR spectroscopic imaging. Chmelík, M., Považan, M., Jírů, F., et al.[2015]

In a study involving 26 healthy subjects, proton magnetic resonance spectroscopy (MRS) showed improved signal-to-noise ratio (SNR) and peak width at 3.0T compared to 1.5T, indicating that higher magnetic fields enhance the quality of brain metabolite measurements.

While some metabolites like creatine and myo-Inositol showed higher concentrations at 3.0T, most metabolite levels remained similar between the two field strengths, suggesting that factors beyond magnetic field strength can influence quantitative results in MRS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of human brain metabolite levels using 1H MRS at 1.5T and 3.0T. Paiva, FF., Otaduy, MCG., de Oliveira-Souza, R., et al.[2022]

Magnetic resonance spectroscopic imaging (MRSI) is a promising technique that allows for in vivo analysis of metabolite density in the human body, which can enhance the accuracy of diagnosing brain diseases.

Recent advancements in high-speed imaging techniques have the potential to reduce the lengthy measurement times of MRSI, making it more feasible for clinical diagnosis and early detection of brain disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advance of magnetic resonance spectroscopic imaging (MRSI) techniques]. Hirata, S., Bito, Y., Yamamoto, E.[2011]

In vivo proton magnetic resonance spectroscopic imaging (1H MRSI) at a high field strength of 9.4 T is feasible, allowing for reliable quantification of 12 metabolites in the human brain, which may be challenging at lower field strengths.

The study highlights the need for further advancements to improve the quality of imaging, particularly in addressing issues like chemical shift displacement and transmit field homogeneity, to fully leverage the sensitivity benefits of 9.4 T MRSI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo proton magnetic resonance spectroscopic imaging of the healthy human brain at 9.4 T: initial experience. Chadzynski, GL., Pohmann, R., Shajan, G., et al.[2022]

Proton magnetic resonance spectroscopy (MRS) is increasingly used alongside MRI for diagnosing brain tumors, but many medical physicists may not be familiar with the specific challenges of MRS.

This paper outlines key technical issues in clinical proton MRS, such as shimming and spatial localization, and offers solutions to common problems, serving as a valuable resource for medical physicists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton magnetic resonance spectroscopy in the brain: report of AAPM MR Task Group #9. Drost, DJ., Riddle, WR., Clarke, GD.[2022]

Magnetic resonance spectroscopy (MRS) and magnetic resonance spectroscopic imaging (MRSI) are valuable non-invasive techniques for assessing brain metabolism, widely used in both clinical and research settings.

The chapter emphasizes the importance of proton MRS in human studies while also noting that many methods can be applied to animal models, highlighting its versatility in evaluating brain health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR spectroscopy and spectroscopic imaging of the brain. Zhu, H., Barker, PB.[2021]

The study evaluated various 3D proton magnetic resonance spectroscopic imaging (1H MRSI) techniques at 3 Tesla, finding that while parallel imaging reduced the signal-to-noise ratio (SNR) by 34-42%, improvements were possible through regularization, indicating potential for enhanced data quality.

The flyback echo-planar spectroscopic imaging (EPSI) method provided excellent quality data with negligible lipid contamination and acceptable SNR values in under 9.5 minutes, making it a promising technique for efficient brain metabolite analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(1)H spectroscopic imaging of human brain at 3 Tesla: comparison of fast three-dimensional magnetic resonance spectroscopic imaging techniques. Zierhut, ML., Ozturk-Isik, E., Chen, AP., et al.[2021]

Using 7 T magnetic resonance spectroscopic imaging (MRSI) on 51 patients with relapsing-remitting multiple sclerosis (MS), researchers found focal metabolic changes that were not visible on conventional MRI, indicating that MRSI can reveal hidden pathology in MS lesions.

The study identified regions with significantly higher levels of myo-inositol (mIns) compared to normal white matter, suggesting that mIns could serve as an early biomarker for lesion development in MS, particularly in areas near cortical gray matter.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lesion-Specific Metabolic Alterations in Relapsing-Remitting Multiple Sclerosis Via 7 T Magnetic Resonance Spectroscopic Imaging. Lipka, A., Niess, E., Dal-Bianco, A., et al.[2023]

Magnetic resonance spectroscopy (MRS) at 7 Tesla provides a higher signal-to-noise ratio (SNR) compared to 3 Tesla, allowing for more precise measurements of brain metabolites across three different brain regions.

The study demonstrated that most metabolites could be measured with greater accuracy at 7T, confirming the advantages of using higher field strength for brain imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of single voxel brain MRS AT 3T and 7T using 32-channel head coils. Pradhan, S., Bonekamp, S., Gillen, JS., et al.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Phosphorus magnetic resonance spectroscopic imaging using flyback echo planar readout trajectories. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Flip-angle mapping of 31P coils by steady-state MR spectroscopic imaging. [2015]

3. Brazil pubmed.ncbi.nlm.nih.gov

Comparison of human brain metabolite levels using 1H MRS at 1.5T and 3.0T. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

[Advance of magnetic resonance spectroscopic imaging (MRSI) techniques]. [2011]

5. Germany pubmed.ncbi.nlm.nih.gov

In vivo proton magnetic resonance spectroscopic imaging of the healthy human brain at 9.4 T: initial experience. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Proton magnetic resonance spectroscopy in the brain: report of AAPM MR Task Group #9. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

MR spectroscopy and spectroscopic imaging of the brain. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

(1)H spectroscopic imaging of human brain at 3 Tesla: comparison of fast three-dimensional magnetic resonance spectroscopic imaging techniques. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Lesion-Specific Metabolic Alterations in Relapsing-Remitting Multiple Sclerosis Via 7 T Magnetic Resonance Spectroscopic Imaging. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of single voxel brain MRS AT 3T and 7T using 32-channel head coils. [2019]