MRS Brain Imaging for Normal Brain Function

Recruiting at 1 trial location

Overseen By Christopher S Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Mental Health (NIMH)

Must not be taking: Anticholinergics, Benzodiazepines, Fluoxetine, others

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

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 2 hours

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how the brain naturally processes glucose into important neurotransmitters, specifically glutamate and GABA, using magnetic resonance spectroscopy (MRS). By understanding these processes, researchers hope to gain insights into normal brain function. The trial suits healthy individuals with no significant medical issues or history of neurological disorders. Participants must be comfortable with MRI procedures and able to lie still for about two and a half hours. As an unphased trial, participants contribute to foundational research that enhances understanding of brain health.

Will I have to stop taking my current medications?

If you are taking prescription psychotropic medications (like anticholinergics, benzodiazepines, fluoxetine, antipsychotics, or anticonvulsants), you need to be off them for at least 8 weeks before joining the study.

What prior data suggests that this MRS method is safe for brain imaging?

Research has shown that Magnetic Resonance Spectroscopy (MRS) is very safe. Unlike some other medical scans, MRS does not use harmful radiation or injected dyes. No known health risks exist from the magnetic fields or radio waves used in MRS. This makes MRS non-invasive and involves minimal risk. Participants can trust the safety of this procedure based on these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRS brain imaging because it offers a unique glimpse into normal brain function, which current methods can't fully capture. Unlike traditional imaging techniques that focus primarily on brain structure, MRS (Magnetic Resonance Spectroscopy) allows scientists to study the chemical composition of brain tissue in a non-invasive way. This can lead to a better understanding of brain metabolism and neurotransmitter activity, opening doors to more targeted and effective treatments for neurological conditions in the future.

What evidence suggests that this MRS device is effective for measuring brain function?

Studies have shown that Magnetic Resonance Spectroscopy (MRS) offers a safe and non-invasive method to examine brain chemistry. It measures changes in specific chemicals to assess how brain cells use energy. Research suggests that MRS can enhance understanding of brain disorders such as tumors and metabolic issues. By analyzing how glucose converts into neurotransmitters like glutamate and GABA, MRS provides insights into brain function. This technique holds promise for revealing brain mechanisms and their potential alterations under various conditions. ^{4 6 7 8 9}

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 adults aged 18-65 who can consent to participate. They must be enrolled in specific protocols, have no serious medical conditions, not use certain psychotropic drugs or substances, and cannot be pregnant or breastfeeding. People with metal implants affected by MRI or claustrophobia are also excluded.

Inclusion Criteria

I am generally healthy according to my doctor's evaluation.

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

Able to give written informed consent

Exclusion Criteria

Positive HIV test

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral administration of [13C]glucose or an intravenous infusion of [13C]glucose and/or [13C]acetate while undergoing MRS to measure neurotransmitter metabolism

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3T and 7T device
• MRS

Trial Overview The study uses advanced MRS technology at different strengths (3T and 7T) to track how the brain processes glucose into neurotransmitters like glutamate and GABA. It's a non-invasive way to understand brain metabolism in healthy individuals.

How Is the Trial Designed?

Group I: One arm Experimental Treatment 1 Intervention

Subjects receive the same test

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

Magnetic resonance spectroscopy (MRS) enhances the specificity of MRI by providing detailed information about neuronal health, cellular energetics, and membrane status, which is crucial for diagnosing neurological conditions.

The article emphasizes the importance of integrating MRS into neuroradiologic evaluations for both adults and children, as it offers valuable insights into various neurologically based diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton magnetic resonance spectroscopy: technique for the neuroradiologist. Cecil, KM.[2021]

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]

Proton magnetic resonance spectroscopy (MRS) can be easily integrated with routine MRI studies to provide valuable metabolic information about pathological tissues, particularly in the brain.

MRS is a crucial tool for diagnosing brain tumors and assessing the effectiveness of radiotherapy, enhancing the overall diagnostic capabilities of MRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Proton magnetic resonance spectroscopy: a metabolic approach of cerebral tumors and their follow-up after external radiation therapy]. Grand, S., Estève, F., Rémy, C., et al.[2019]

In a study of 8 patients with medulloblastoma, proton MR spectroscopy (MRS) showed promising prognostic value, correlating well with MRI results and tumor pathology after preoperative chemotherapy.

Patients who exhibited favorable changes in MRS, such as increased NAA and decreased Cr, had better outcomes, remaining alive and disease-free, while those with poor MRS responses tended to have worse prognoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Can proton magnetic resonance spectroscopy be of any value as a prognostic factor in medulloblastoma?]. Dembowska-Bagińska, B., Perek, D., Perek-Polnik, M., et al.[2019]

3T proton MR spectroscopy (1H MRS) showed a significant increase in signal-to-noise ratios (SNRs) of cerebral metabolites by 49-73% at a short echo time (TE) compared to 1.5T, indicating improved detection of brain tumor metabolites.

While 3T provided slightly better spectral resolution at a short TE, there was no significant difference in metabolite ratios between the two field strengths, suggesting that while 3T enhances certain aspects of imaging, it does not fundamentally change the interpretation of metabolite ratios in brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 1.5T and 3T 1H MR spectroscopy for human brain tumors. Kim, JH., Chang, KH., Na, DG., et al.[2018]

Proton magnetic resonance spectroscopy (MRS) has evolved into a clinically valuable tool for brain analysis, providing insights into metabolic and biochemical information through the detection of various resonances.

The review highlights three key clinical applications where MRS has demonstrated diagnostic value, emphasizing its reproducibility and effectiveness at different magnetic field strengths (1.5 and 3-4 T).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in magnetic resonance neurospectroscopy. Rosen, Y., Lenkinski, RE.[2020]

MR spectroscopy (MRS) is a promising noninvasive technique for assessing biochemical metabolism in human tissues, but its use in clinical settings has been limited, primarily to specialized institutions.

With the increasing availability of 3-T clinical MR scanners, there is a significant opportunity to integrate MRS into routine clinical practice, supported by updated consensus guidelines and ongoing research into multinuclear MRS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo Human MR Spectroscopy Using a Clinical Scanner: Development, Applications, and Future Prospects. Tomiyasu, M., Harada, M.[2022]

Clinical neuroimaging spectroscopy at 3T has significantly improved the detection and quantification of brain metabolites like glutamate, glutamine, and GABA, enhancing the characterization of various brain diseases.

With over 250 scans conducted since 2005, the use of higher magnetic fields has led to better signal quality and more accurate postprocessing, making brain MR spectroscopy more effective and user-friendly for neuroradiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain (1)H-MR spectroscopy in clinical neuroimaging at 3T. Jissendi Tchofo, P., Balériaux, D.[2019]

A study involving 13 healthy volunteers demonstrated that short echo time proton MR spectroscopy (1H-MRS) is reproducible, with consistent measurements taken on the same day and two months apart.

The results showed no significant differences in metabolite ratios over time, indicating that 1H-MRS can reliably monitor brain metabolites, which may be useful for observing central nervous system diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproducibility of short echo time proton magnetic resonance spectroscopy using point-resolved spatially localized spectroscopy sequence in normal human brains. Hoshino, Y., Yoshikawa, K., Inoue, Y., et al.[2013]

Magnetic resonance spectroscopy (MRS) using the PROBE software is a valuable tool for assessing brain metabolism and abnormalities, particularly in children with brain tumors, and can be performed in a clinical setting.

The study highlights the differences in MRS spectra among infants, children, and adults, which is crucial for accurately diagnosing brain conditions based on metabolic activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance spectroscopy (MRS) in the evaluation of pediatric brain tumors, Part I: Introduction to MRS. Byrd, SE., Tomita, T., Palka, PS., et al.[2018]

Proton MR spectroscopy is a powerful tool that can differentiate between normal and abnormal brain tissue, offering greater tissue specificity than traditional imaging methods.

This technique is particularly useful in diagnosing various conditions, including brain tumors, postradiation changes, infections, and degenerative disorders, by visualizing metabolite concentrations and their distribution within lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton MR spectroscopy in neoplastic and non-neoplastic brain disorders. Castillo, M., Kwock, L., Scatliff, J., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1064986/

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, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923006402

Recent Advances in Magnetic Resonance ... In cases where MRI reveals no distinct lesions, MRS can provide a noninvasive assessment of the underlying metabolic status of the tissue being studied. This is ...

3. aetna.com aetna.com/cpb/medical/data/200_299/0202.html

Magnetic Resonance Spectroscopy (MRS) - Medical ... Magnetic resonance spectroscopy (MRS) in the evaluation of brain tumors (either primary tumors or brain metastases) is considered experimental, investigational ...

4. nature.com nature.com/articles/pr19982181

Proton Magnetic Resonance Spectroscopy: An Emerging ... Proton magnetic resonance spectroscopy (MRS) is an emerging technology that allows for the quantitative noninvasive assessment of regional brain biochemistry.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7179569/

A Methodological Consensus on Clinical Proton MR ... Proton Magnetic Resonance Spectroscopy (1H MRS) has provided a non-invasive measure of brain metabolites since the late 1980s. Abnormal metabolism is often ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8272438/

Clinical applications of magnetic resonance spectroscopy ... MRS requires no injected contrast agent and no ionizing radiation is involved, which are obvious safety benefits. There are many applications of ...

7. mayfieldclinic.com mayfieldclinic.com/pe-mrspectroscopy.htm

Magnetic Resonance Spectroscopy, MR ... What are the risks? MRI and MR spectroscopy are very safe. There are no known health risks associated with the magnetic field or the radio waves used by the ...

8. mainehealth.org mainehealth.org/care-services/diagnostic-imaging-radiology/magnetic-resonance-spectroscopy-mrs

Magnetic Resonance Spectroscopy | MRS Magnetic resonance spectroscopy (MRS) is a non-invasive diagnostic test for measuring biochemical changes in the brain, especially the presence of tumors.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0720048X03002420

High-field proton MRS of human brain Proton magnetic resonance spectroscopy (1H-MRS) of the brain reveals specific biochemical information about cerebral metabolites, which may support clinical ...