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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01EB027087-01 | U.S. NIH Grant/Contract | View source | |
| A539300 | Other Identifier | University of Wisconsin, Madison | |
| SMPH/RADIOLOGY/RADIOLOGY | Other Identifier | University of Wisconsin, Madison | |
| Protocol Version 4/8/2024 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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The overall purpose of this research is to determine whether new macromolecular measures optimized for whole brain (gray matter and white matter) magnetic resonance imaging (MRI), predict neuro-cognitive impairment in multiple sclerosis (MS) patients.
MRI is a vital component of a MS work-up, providing noninvasive evidence of MS lesions, detecting active inflammatory lesions, and measuring brain atrophy to assess neurodegeneration. Recent years of MRI research have generated strong evidence of gray matter (GM) involvement in MS, resulting in the reclassification of MS as a whole-brain disease. Similar to white matter (WM), a primary target of MS pathology in GM is myelin, the protective sheath insulating the penetrating axons within GM and extending brain connectivity all the way to the neuronal bodies.
This aim of this research is to examine if the associations between imaging measures of GM disease and cognitive performance can establish GM-based imaging correlates predicting the disease course and accurately assessing treatment results.
This observational research will enroll adults diagnosed with MS both with and without cognitive impairment. Subjects will be asked to complete a single research visit that includes the administration of a MRI scan and a neuro-cognitive testing session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Impairment | Adults diagnosed with MS that have evidence of cognitive decline. |
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| No Cognitive Impairment | Adults diagnosed with MS that have no evidence of cognitive decline. |
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| Healthy Controls | Healthy adult volunteers will form a control group matched for age, gender, education, handedness |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Diagnostic Test | The MRI protocol will include conventional testing for MS lesion detection and functional MR imaging to localize associated neurocognitive domains in each subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of macromolecular proton content (MPC) by Magnetic resonance imaging | Macromolecular Proton Fraction (MPF) is calculated from several specially acquired MR images and is characterized by high degree of sensitivity and specificity to tissue macromolecules, which are the main target of pathological process in neurodegenerative diseases including multiple sclerosis (MS). These properties of MPF are in contrast with standard MR images, which are primarily sensitive to tissue water molecules. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive performance as measured by Minimal Assessment of Cognitive Function in MS (MACFIMS) battery of neuropsychological (NP) tests | The results of Minimal Assessment of Cognitive Function in MS (MACFIMS) battery of neuropsychological (NP) tests will form the secondary outcome measure. The NP scores will be correlated with MPF to study association between macromolecular tissue damage and neurocognitive performance. |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for Healthy Controls:
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Adults diagnosed with MS both with and without evidence of cognitive impairment.
Healthy controls will be recruited from the MRI Volunteer Database (2017-0004, PI: Reeder)
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| Name | Affiliation | Role |
|---|---|---|
| Alexey Samsonov, PhD | UW Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin, Madison | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Neuropsychological Testing | Diagnostic Test | A comprehensive battery of neuropsychological tests will be administered to assess memory, new learning, spatial processing and higher executive function. |
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| 24 hours |
| Neurocognitive performance as measured by the Montreal Cognitive Assessment (MoCA) score | Neurocognitive performance will be measured by Montreal Cognitive Assessment. MoCA scores range from 0 to 30, higher values corresponding to better cognitive performances. | 24 hours |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |