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Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04415372
Recruitment Status : Suspended (Suspended due to COVID-19)
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Sclerosis MS Diagnostic Test: MRI Diagnostic Test: Neuropsychological Testing

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cognitive Impairment
Adults diagnosed with MS that have evidence of cognitive decline.
Diagnostic Test: MRI
The MRI protocol will include conventional testing for MS lesion detection and functional MR imaging to localize associated neurocognitive domains in each subject.
Other Name: Functional MRI

Diagnostic Test: Neuropsychological Testing
A comprehensive battery of neuropsychological tests will be administered to assess memory, new learning, spatial processing and higher executive function.

No Cognitive Impairment
Adults diagnosed with MS that have no evidence of cognitive decline.
Diagnostic Test: MRI
The MRI protocol will include conventional testing for MS lesion detection and functional MR imaging to localize associated neurocognitive domains in each subject.
Other Name: Functional MRI

Diagnostic Test: Neuropsychological Testing
A comprehensive battery of neuropsychological tests will be administered to assess memory, new learning, spatial processing and higher executive function.




Primary Outcome Measures :
  1. Measurement of macromolecular proton content (MPC) by Magnetic resonance imaging [ Time Frame: 24 hours ]
    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.


Secondary Outcome Measures :
  1. Neurocognitive performance as measured by Minimal Assessment of Cognitive Function in MS (MACFIMS) battery of neuropsychological (NP) tests [ Time Frame: 24 hours ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults diagnosed with MS both with and without evidence of cognitive impairment.
Criteria

Inclusion Criteria:

  • Clinically definite MS
  • Adult age 18 to 60

Exclusion Criteria:

  • Contraindication to MRI
  • Changes in MS therapy in the last 6 months
  • Less than 6 weeks after relapse or corticosteroid use
  • Currently taking medication that may affect cognition (e.g. donepezil, rivastigmine, adderall)
  • History of significant alcohol or drug abuse
  • Current or recent significant migraines
  • Confounding neurological or cognitive disorders or deficits (stroke, Parkinson's disease, dementia due to any etiology)
  • Sensory or physical impairments that might interfere significantly with cognitive testing
  • History of developmental or learning disability or attention-deficit/hyperactivity disorder.\

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04415372


Locations
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United States, Wisconsin
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Principal Investigator: Alexey Samsonov, PhD UW Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04415372    
Other Study ID Numbers: 2020-0310
1R01EB027087-01 ( U.S. NIH Grant/Contract )
A539300 ( Other Identifier: University of Wisconsin, Madison )
SMPH/RADIOLOGY/RADIOLOGY ( Other Identifier: University of Wisconsin, Madison )
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Wisconsin, Madison:
Magnetic resonance imaging
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases