Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01266577
First received: December 23, 2010
Last updated: June 25, 2014
Last verified: May 2014
  Purpose

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.

Condition
Brain Mapping
Healthy Volunteer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The primary outcome is the quality of the MR spectroscopy which includes spectrum signal-to-noise (SNR) ratio, spectral lineshape, linewidth, and resolution.

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

Estimated Enrollment: 150
Study Start Date: December 2010
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 (31P) 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.

31P MRS can be utilized to measure energy phosphate metabolites of inorganic phosphate (Pi), phosphocreatine (PCr), 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.

This protocol proposes two main goals. First, to implement and optimize current proton and 31P 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.

To develop and optimize in vivo MRS methods, 150 healthy volunteers will be recruited over a period of three 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • 18-65 years of age
  • in good health, as indicated by the medical evaluation and screening at the NIH

EXCLUSION CRITERIA:

  • have been diagnosed or treated for any psychiatric illness in the last 90 days
  • history of drug abuse in the last 90 days, being defined as any use of an illicit substance, or use of a prescription or over the counter medication for reasons or in amounts, other than instructed use. (caffeine and nicotine are not exclusionary)
  • in the last 90 days, have history of alcohol abuse or dependence, or have more than moderate alcohol consumption defined as a daily average of four or more ounces for men or three or more ounces for women. (one ounce being considered to be equal to one beer, one glass of wine or one mixed drink)
  • serious medical illness likely to modify brain anatomy and/or physiology, such as heart disease, liver disease, hypertension, kidney disease, diabetes, or a seizure disorder.
  • claustrophobic inside the MRI scanner
  • metallic (ferromagnetic) implants, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, shrapnel fragments, and possible small metal fragments in the eye
  • unable to lie flat on back for up to 2 hours
  • past brain surgery
  • pregnant
  • unable or unwilling to sign an informed consent document
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266577

Contacts
Contact: Christopher Johnson (301) 402-6695 johnsonchri@mail.nih.gov
Contact: Shizhe Steve Li, Ph.D. (301) 435-8859 steveli@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Shizhe Steve Li, Ph.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01266577     History of Changes
Other Study ID Numbers: 110045, 11-M-0045
Study First Received: December 23, 2010
Last Updated: June 25, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Brain Metabolism
Neurochemistry
Magnetic Resonance Imaging
Mental Illness
Magnetic Resonance Spectroscopy
Healthy Volunteer
HV

ClinicalTrials.gov processed this record on September 18, 2014