NCT00109174

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
47mo left

Started Sep 2006

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 Progress84%
Sep 2006Mar 2030

First Submitted

Initial submission to the registry

April 22, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2005

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 6, 2006

Completed
23.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2030

Last Updated

April 20, 2026

Status Verified

August 8, 2025

Enrollment Period

23.4 years

First QC Date

April 22, 2005

Last Update Submit

April 17, 2026

Conditions

Keywords

GlutamateExcitatory Amino AcidNeurochemistryBrainMagnetic 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

    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 test

Device: 3T and 7T device

Interventions

3T and 7T device

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
  • Prescription psychotropic medication; drug free less than 8 weeks (anticholinergics, benzodiazepine, fluoxetine, antipsychotics, and anticonvulsants)
  • Serious medical illness as determined from H\&P or laboratory testing including Diabetes
  • 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 Links

Study Officials

  • Li An, Ph.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher S Johnson

CONTACT

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

April 22, 2005

First Posted

April 25, 2005

Study Start

September 6, 2006

Primary Completion (Estimated)

January 11, 2030

Study Completion (Estimated)

March 11, 2030

Last Updated

April 20, 2026

Record last verified: 2025-08-08

Locations