MRI and MRS Brain Scans for Brain Mapping in Healthy Subjects

Recruiting at 1 trial location

Overseen By Christopher S 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on developing and improving brain imaging techniques using MRI (magnetic resonance imaging) and MRS (magnetic resonance spectroscopy). These advanced scans help researchers study brain chemistry and activity, aiding in the creation of new treatments for psychiatric conditions. The trial seeks healthy individuals who haven't had an MRI in the last year and have no history of neurological illness or mental health diagnosis. Participants will undergo a screening and a brain scan at the National Institutes of Health Clinical Center. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to innovative treatments for mental health conditions.

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 prior data suggests that these MRI and MRS techniques are safe?

Research shows that Magnetic Resonance Spectroscopy (MRS) provides a safe and non-invasive way to study the brain. It has been used with both healthy individuals and those with brain conditions. Studies confirm that MRS does not use harmful radiation, making it a well-tolerated option for brain imaging.

There is little evidence of significant side effects or problems. Most participants handle the procedure well. Those familiar with a regular MRI will find the experience quite similar. Participants lie still while the machine takes detailed images and measures brain chemicals.

Overall, MRS offers a safe method to explore brain activity and chemistry, aiding researchers in developing new treatments for mental health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Magnetic Resonance Spectroscopic Imaging (MRSI) for brain mapping because it offers a non-invasive way to study brain chemistry in detail. Unlike traditional MRI, which provides images of brain structure, MRSI can measure the concentration of various brain chemicals, offering insights into brain function and metabolism. This technique could revolutionize how we understand healthy brain activity and potentially lead to earlier detection of neurological disorders.

What evidence suggests that MRI and MRS techniques are effective for brain mapping?

Research has shown that magnetic resonance spectroscopy (MRS) is useful for studying brain chemistry. MRS, a special type of MRI, measures important brain chemicals. Studies have found that MRS can observe energy changes in the brain during activities like visual tasks. It measures molecules involved in energy production, such as phosphocreatine and adenosine triphosphate. These findings suggest that MRS can help researchers understand brain function and might lead to new treatments for mental health conditions in the future. ^{6 7 8 9 10}

Who Is on the Research Team?

Li An, Ph.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Are You a Good Fit for This Trial?

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

Able to give written informed consent

Enrolled in Protocol 01-M-0254 or Protocol 17-M-0181

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

I do not have a history of major neurological illnesses like MS, Parkinson's, seizures, or brain injuries.

Clinically significant laboratory abnormalities

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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pmc.ncbi.nlm.nih.gov

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Functional 31P Magnetic Resonance Spectroscopy at 9.4 T

Functional 31 P MRS in healthy subjects at 9.4 T was applied to investigate changes in the energy metabolism of the brain during visual stimulation.

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31 P-MRS is a non-invasive method which allows for the measurement of OXPHOS-related high-energy phosphates (HEP), including phosphocreatine (PCr), adenosine ...

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Development of a 31P magnetic resonance spectroscopy ...

We here develop a non-invasive Phosphorous Magnetic Resonance Spectroscopy (31P-MRS) method to quantify these metabolites in human skeletal ...

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sciencedirect.com

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Efficacy of Proton Magnetic Resonance Spectroscopy in ...

In this review, we will cover how MRS provides therapeutic impact in brain tumors, metabolic disorders such as adrenoleukodystrophy and Canavan's disease, ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1053811917305852

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Magnetic Resonance Spectroscopy (MRS) allows for a non-invasive and non-ionizing determination of in vivo tissue concentrations and metabolic turn-over rates of ...

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Magnetic Resonance Spectroscopy - Yale School of Medicine

Ever since the discovery of Magnetic Resonance Imaging (MRI), the field of MR has diverged into MRI and Magnetic Resonance Spectroscopy (MRS). Whereas MRI.