Multiple Sclerosis Clinical Trial

Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

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.

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Full 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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Eligibility 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, 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.

Exclusion Criteria for Healthy Controls:

history of alcohol/drug abuse
history of migraines
developmental or learning disability/attention-deficit/hyperactivity disorder
currently pregnant/breastfeeding

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

75

Study ID:

NCT04415372

Recruitment Status:

Enrolling by invitation

Sponsor:

University of Wisconsin, Madison

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There is 1 Location for this study

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University of Wisconsin, Madison
Madison Wisconsin, 53705, United States

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Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

75

Study ID:

NCT04415372

Recruitment Status:

Enrolling by invitation

Sponsor:


University of Wisconsin, Madison

How clear is this clinincal trial information?

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