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

This study is currently recruiting participants.
Verified July 26, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01266577
First Posted: December 24, 2010
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
December 23, 2010
December 24, 2010
December 14, 2017
December 23, 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. [ Time Frame: Ongoing ]
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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. [ Time Frame: Ongoing ]
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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
Observational Model: Other
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
300
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  • INCLUSION CRITERIA:
  • 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

EXCLUSION CRITERIA:

  • 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.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
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 Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
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)
July 26, 2017