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

December 23, 2010
June 25, 2014
December 2010
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The primary outcome is the quality of the MR spectroscopy which includes spectrum signal-to-noise (SNR) ratio, spectral lineshape, linewidth, and resolution.
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Complete list of historical versions of study NCT01266577 on ClinicalTrials.gov Archive Site
The secondary outcome is the performance improvements of the scanner hardware, software and methodology.
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Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle

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.

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.

Observational
Time Perspective: Prospective
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  • Brain Mapping
  • Healthy Volunteer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
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  • 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
Both
18 Years to 65 Years
Yes
Contact: Christopher Johnson (301) 402-6695 johnsonchri@mail.nih.gov
Contact: Shizhe Steve Li, Ph.D. (301) 435-8859 steveli@mail.nih.gov
United States
 
NCT01266577
110045, 11-M-0045
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National Institute of Mental Health (NIMH)
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Principal Investigator: Shizhe Steve Li, Ph.D. National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP