NCT01266577

Brief 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 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....

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jan 2011Oct 2026

First Submitted

Initial submission to the registry

December 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 27, 2011

Completed
15.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2026

Last Updated

April 29, 2026

Status Verified

April 6, 2026

Enrollment Period

15.7 years

First QC Date

December 23, 2010

Last Update Submit

April 28, 2026

Conditions

Brain MappingHealthy Volunteer

Keywords

Brain MetabolismNeurochemistryMagnetic Resonance ImagingMental IllnessMagnetic Resonance Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • 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

    prospective and ongoing

Secondary Outcomes (1)

  • The secondary outcome is the performance improvements of the scanner hardware, software and methodology.

    prospective and ongoing

Study Arms (1)

One Arm

OTHER

Subjects receive the same scan

Other: NSR MAGNETOM 7TOther: 1Tx x 32Rx Head Coil

Interventions

NSR MAGNETOM 7TOTHER

The 7 Tesla scanner is a magnet system used to acquire magnetic resonance imaging and spectroscopy

One Arm
1Tx x 32Rx Head CoilOTHER

Used to perform proton imaging and spectroscopy in the human heads.

One Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37500714DERIVED

Related Links

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Li An, Ph.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher S Johnson

CONTACT

(301) 402-6695johnsonchri@mail.nih.gov

Li An, Ph.D.

CONTACT

(301) 896-2882anl@mail.nih.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2010

First Posted

December 24, 2010

Study Start

January 27, 2011

Primary Completion (Estimated)

October 23, 2026

Study Completion (Estimated)

October 23, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04-06

Locations

US(1)