Healthy Volunteer Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | October 23, 2026 |
Est. primary completion date | January 24, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | - 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The secondary outcome is the performance improvements of the scanner hardware, software and methodology. | to obtain more accurate and reliable MRS data from the human brain and muscle | prospective and ongoing |
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