Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis
NCT ID: NCT04415372
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
75 participants
OBSERVATIONAL
2021-11-19
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cognitive Impairment
Adults diagnosed with MS that have evidence of cognitive decline.
MRI
The MRI protocol will include conventional testing for MS lesion detection and functional MR imaging to localize associated neurocognitive domains in each subject.
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.
MRI
The MRI protocol will include conventional testing for MS lesion detection and functional MR imaging to localize associated neurocognitive domains in each subject.
Neuropsychological Testing
A comprehensive battery of neuropsychological tests will be administered to assess memory, new learning, spatial processing and higher executive function.
Healthy Controls
Healthy adult volunteers will form a control group matched for age, gender, education, handedness
MRI
The MRI protocol will include conventional testing for MS lesion detection and functional MR imaging to localize associated neurocognitive domains in each subject.
Interventions
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MRI
The MRI protocol will include conventional testing for MS lesion detection and functional MR imaging to localize associated neurocognitive domains in each subject.
Neuropsychological Testing
A comprehensive battery of neuropsychological tests will be administered to assess memory, new learning, spatial processing and higher executive function.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult age 18 to 60
Exclusion Criteria
* 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, Alzheimer's disease, epilepsy)
* Sensory or physical impairments that might interfere significantly with cognitive testing
* History of developmental or learning disability or attention-deficit/hyperactivity disorder.\\
* history of alcohol/drug abuse
* history of migraines
* developmental or learning disability/attention-deficit/hyperactivity disorder
* currently pregnant/breastfeeding
18 Years
60 Years
ALL
Yes
Sponsors
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National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Alexey Samsonov, PhD
Role: PRINCIPAL_INVESTIGATOR
UW Madison
Locations
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University of Wisconsin, Madison
Madison, Wisconsin, United States
Countries
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Other Identifiers
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A539300
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/RADIOLOGY/RADIOLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 4/8/2024
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0310
Identifier Type: -
Identifier Source: org_study_id
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