MRS Brain Imaging for Normal Brain Function

Recruiting at 1 trial location

Overseen By Christopher 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

Trial Summary

What is the purpose of this trial?

This study will use magnetic resonance spectroscopy (MRS) to measure in the brain the transfer of \[13\]C as it is naturally metabolized from glucose to specific chemical transmitters. From this method, we can measure the rate of production of an important excitatory neurotransmitter (glutamate) as well as an inhibitory neurotransmitter (GABA)....

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 data supports the effectiveness of the treatment 3T and 7T device, 3 Tesla device, 7 Tesla device, Magnetic Resonance Spectroscopy (MRS) device, MRS, Magnetic Resonance Spectroscopy, MR Spectroscopy, Proton MRS for normal brain function?

Research shows that using higher magnetic fields like 3T in brain proton spectroscopy improves the clarity and detail of brain scans, helping to better identify and understand various brain conditions. This suggests that the treatment could be effective in providing detailed insights into normal brain function. ^{1 2 3 4 5}

Is MRS brain imaging safe for humans?

Proton magnetic resonance spectroscopy (MRS) is a noninvasive technique used to analyze brain tissue and is generally considered safe for humans. It is often used alongside MRI to provide additional metabolic information and has been applied in various clinical settings without significant safety concerns. ^{4 6 7 8 9}

How is MRS treatment different from other treatments for normal brain function?

MRS (Magnetic Resonance Spectroscopy) is unique because it is a noninvasive technique that analyzes the chemical composition of brain tissue, providing detailed metabolic information that other imaging methods cannot. Unlike traditional imaging, MRS can differentiate between normal and abnormal brain tissue by mapping metabolite concentrations, making it particularly useful for understanding brain function and disorders. ^{3 4 5 10 11}

Research Team

Li An, Ph.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Eligibility Criteria

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.

Clinically significant laboratory abnormalities

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of 1.5T and 3T 1H MR spectroscopy for human brain tumors. [2018]

2. France pubmed.ncbi.nlm.nih.gov

Brain (1)H-MR spectroscopy in clinical neuroimaging at 3T. [2019]

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

Recent advances in magnetic resonance neurospectroscopy. [2020]

4. Poland pubmed.ncbi.nlm.nih.gov

[Can proton magnetic resonance spectroscopy be of any value as a prognostic factor in medulloblastoma?]. [2019]

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

Proton MR spectroscopy in neoplastic and non-neoplastic brain disorders. [2015]

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

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

7. France pubmed.ncbi.nlm.nih.gov

[Proton magnetic resonance spectroscopy: a metabolic approach of cerebral tumors and their follow-up after external radiation therapy]. [2019]

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

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

9. Japan pubmed.ncbi.nlm.nih.gov

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

10. Japan 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. [2013]

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

Magnetic resonance spectroscopy (MRS) in the evaluation of pediatric brain tumors, Part I: Introduction to MRS. [2018]