Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

University of Wisconsin (UW)

Status: Invitation-only

Conditions: Multiple Sclerosis; MS

Treatments: Diagnostic Test: Neuropsychological Testing; Diagnostic Test: MRI

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04415372

SMPH/RADIOLOGY/RADIOLOGY (Other Identifier)

2020-0310

Protocol Version 4/8/2024 (Other Identifier)

A539300 (Other Identifier)

1R01EB027087-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

75 participants in 3 patient groups

Cognitive Impairment

Description:

Adults diagnosed with MS that have evidence of cognitive decline.

Treatment:

Diagnostic Test: MRI

Diagnostic Test: Neuropsychological Testing

No Cognitive Impairment

Description:

Adults diagnosed with MS that have no evidence of cognitive decline.

Treatment:

Diagnostic Test: MRI

Diagnostic Test: Neuropsychological Testing

Healthy Controls

Description:

Healthy adult volunteers will form a control group matched for age, gender, education, handedness

Treatment:

Diagnostic Test: MRI