Brain MappingNCT01266577
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
A study testing NSR MAGNETOM 7T and 1Tx x 32Rx Head Coil in people with Brain Mapping and Healthy Volunteer, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Mapping, Healthy Volunteer
- What is being tested?
- NSR MAGNETOM 7T and 1Tx x 32Rx Head Coil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2011to 23 Oct 2027
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- able to give written informed consent
- healthy based on medical history and physical exam
- enrolled in Protocol 01-M-0254 or Protocol 17-M-0181
Who cannot join
- Any current Axis 1 diagnosis
- Clinically significant laboratory abnormalities
- Positive HIV test
- 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.
- History of neurological illness or injury with the potential to affect study data interpretation, such as multiple sclerosis, Parkinson s disease, seizure disorder or traumatic brain injury
- Inability to lie flat on camera bed for about two and a half hours
Show all 9Show fewer
- Pregnant or breastfeeding
- Current substance use disorder based on DSM-5
- NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.
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
About this study
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.
Read more
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.
Read the detailed description
Magnetic resonance spectroscopy (MRS) is identical to MRI except that the metabolite signal, rather than the dominant water signal, is measured. Proton (1H) MRS and phosphorous (P) MRS are two powerful spectroscopy methods to measure metabolism in vivo.
By using water suppression techniques, proton MRS can monitor levels of important brain metabolites and neurotransmitters such as N-acetylaspartate (NAA), creatine, choline, lactate, myo-inositol, glutamate, glutamine, gamma aminobutyric acid (GABA), and glutathione.
P MRS can be utilized to measure energy phosphate metabolites of inorganic phosphate (Pi), phosphocreatine (PCr), adenosine diphosphate (ADP), and adenosine triphosphate (ATP) in brain and muscle. In addition, phosphocholine (PC), phosphoethanolamine (PE), glycerophosphocholine (GPC) and glyceophosphoethanolamine (GPE) can also be detected in brain tissues.<TAB>
This protocol proposes three main goals. First, to implement and optimize current proton and P MRS methods published in the literature for the imaging of metabolites in human brain and muscle. Second, to further develop new methods for use in similar brain and muscle MRS applications. Third, to exchange MRS data with other studies in order to provide data analysis and quality control for the studies under this, other NIH, or outside protocols.
To develop and optimize in vivo MRS methods, 300 healthy volunteers will be recruited over a period of ten years. The subjects will be aged 18-65 years, and include representative numbers of males, females, and minorities.
The experiments will be performed on the GE 3T, Siemens 3T and 7T MRI scanners located at the NIH In Vivo NMR Research Center. In the first portion of the study, a clinical MRI will be performed to ensure the subject has no abnormal brain conditions. In the second portion of the study, MRS scans will be performed in various system and pulse parameter combinations. No medications will be involved. Total scan time during the MRS scan will be one to two hours long.
We expect to obtain high quality proton and/or phosphorous spectroscopy imaging from healthy volunteers that will help establish accurate and reliable spectroscopy methods for clinical investigators to perform non-invasive studies of psychiatric, neurological disorders, and other diseases in human brain or muscle.
- Conditions
- Brain Mapping, Healthy Volunteer
- Being tested
- NSR MAGNETOM 7T, 1Tx x 32Rx Head Coil
- Keywords
- Brain Metabolism, Neurochemistry, Magnetic Resonance Imaging, Mental Illness, Magnetic Resonance Spectroscopy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSR MAGNETOM 7TOther
The 7 Tesla scanner is a magnet system used to acquire magnetic resonance imaging and spectroscopy
1Tx x 32Rx Head CoilOther
Used to perform proton imaging and spectroscopy in the human heads.
| Study group | Role | What they receive |
|---|---|---|
| One Arm | Other | Subjects receive the same scan Receives: Other: NSR MAGNETOM 7T; Other: 1Tx x 32Rx Head Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the quality of the MR spectroscopy which includes spectrum signal-to-noise (SNR) ratio, spectral lineshape, linewidth, and resolution.
to obtain more accurate and reliable MRS data from the human brain and muscle
Measured: prospective and ongoing
Secondary outcomes (1)
The secondary outcome is the performance improvements of the scanner hardware, software and methodology.
to obtain more accurate and reliable MRS data from the human brain and muscle
Measured: prospective and ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study start27 Jan 2011
- Primary completion23 Oct 2027 (estimated)
- Study completion23 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain MappingStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Li An, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266577
- Sponsor's protocol ID
- 110045
- Other IDs
- 11-M-0045
- Status last verified
- 6 Apr 2026
- First submitted
- 23 Dec 2010
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
An L, Shen J. In vivo magnetic resonance spectroscopy by transverse relaxation encoding with narrowband decoupling. Sci Rep. 2023 Jul 27;13(1):12211. doi: 10.1038/s41598-023-39375-0.
PubMed 37500714
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
- ClinicalTrials.gov ID
- NCT01266577
- Acronym / sponsor ID
- 110045
- Conditions
- Brain Mapping, Healthy Volunteer
- Keywords
- Brain Metabolism, Neurochemistry, Magnetic Resonance Imaging, Mental Illness, Magnetic Resonance Spectroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 27 Jan 2011 (actual)
- Primary completion
- 23 Oct 2027 (estimated)
- Study completion
- 23 Oct 2027 (estimated)
- First posted
- 24 Dec 2010 (estimated)
- 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 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.
Detailed description
Magnetic resonance spectroscopy (MRS) is identical to MRI except that the metabolite signal, rather than the dominant water signal, is measured. Proton (1H) MRS and phosphorous (P) MRS are two powerful spectroscopy methods to measure metabolism in vivo.
By using water suppression techniques, proton MRS can monitor levels of important brain metabolites and neurotransmitters such as N-acetylaspartate (NAA), creatine, choline, lactate, myo-inositol, glutamate, glutamine, gamma aminobutyric acid (GABA), and glutathione.
P MRS can be utilized to measure energy phosphate metabolites of inorganic phosphate (Pi), phosphocreatine (PCr), adenosine diphosphate (ADP), and adenosine triphosphate (ATP) in brain and muscle. In addition, phosphocholine (PC), phosphoethanolamine (PE), glycerophosphocholine (GPC) and glyceophosphoethanolamine (GPE) can also be detected in brain tissues.<TAB>
This protocol proposes three main goals. First, to implement and optimize current proton and P MRS methods published in the literature for the imaging of metabolites in human brain and muscle. Second, to further develop new methods for use in similar brain and muscle MRS applications. Third, to exchange MRS data with other studies in order to provide data analysis and quality control for the studies under this, other NIH, or outside protocols.
To develop and optimize in vivo MRS methods, 300 healthy volunteers will be recruited over a period of ten years. The subjects will be aged 18-65 years, and include representative numbers of males, females, and minorities.
The experiments will be performed on the GE 3T, Siemens 3T and 7T MRI scanners located at the NIH In Vivo NMR Research Center. In the first portion of the study, a clinical MRI will be performed to ensure the subject has no abnormal brain conditions. In the second portion of the study, MRS scans will be performed in various system and pulse parameter combinations. No medications will be involved. Total scan time during the MRS scan will be one to two hours long.
We expect to obtain high quality proton and/or phosphorous spectroscopy imaging from healthy volunteers that will help establish accurate and reliable spectroscopy methods for clinical investigators to perform non-invasive studies of psychiatric, neurological disorders, and other diseases in human brain or muscle.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Arm | Other | Other: NSR MAGNETOM 7T, Other: 1Tx x 32Rx Head CoilSubjects receive the same scan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years of age
- able to give written informed consent
- healthy based on medical history and physical exam
- enrolled in Protocol 01-M-0254 or Protocol 17-M-0181
Key exclusion criteria (9 listed)
- Any current Axis 1 diagnosis
- Clinically significant laboratory abnormalities
- Positive HIV test
- 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.
- History of neurological illness or injury with the potential to affect study data interpretation, such as multiple sclerosis, Parkinson s disease, seizure disorder or traumatic brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSR MAGNETOM 7TThe 7 Tesla scanner is a magnet system used to acquire magnetic resonance imaging and spectroscopy | Other | One Arm |
| 1Tx x 32Rx Head CoilUsed to perform proton imaging and spectroscopy in the human heads. | Other | One Arm |
Primary outcome
The primary outcome is the quality of the MR spectroscopy which includes spectrum signal-to-noise (SNR) ratio, spectral lineshape, linewidth, and resolution.
Time frame: prospective and ongoing
to obtain more accurate and reliable MRS data from the human brain and muscle
1 secondary outcome
The secondary outcome is the performance improvements of the scanner hardware, software and methodology.
Time frame: prospective and ongoing
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 6 Nov 2026.
- Derived from this study: PubMed 37500714An L, Shen J. In vivo magnetic resonance spectroscopy by transverse relaxation encoding with narrowband decoupling. Sci Rep. 2023 Jul 27;13(1):12211. doi: 10.1038/s41598-023-39375-0.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Li An, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSR MAGNETOM 7T and 1Tx x 32Rx Head Coil in people with Brain Mapping and Healthy Volunteer, run by National Institute of Mental Health (NIMH) 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 4 inclusion and 9 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 6 Nov 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 Christopher S Johnson ((301) 402-6695, johnsonchri@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the quality of the MR spectroscopy which includes spectrum signal-to-noise (SNR) ratio, spectral lineshape, linewidth, and resolution. (time frame: prospective and ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01266577, which also lists 1 linked publication.
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 6 Nov 2026.