Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

NCT ID: NCT04415372

Last Updated: 2025-04-22

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-19

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis MS

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cognitive Impairment

Adults diagnosed with MS that have evidence of cognitive decline.

MRI

Intervention Type 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.

Neuropsychological Testing

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type 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.

Neuropsychological Testing

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type 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.

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.

Intervention Type DIAGNOSTIC_TEST

Neuropsychological Testing

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Functional MRI

Eligibility Criteria

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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.\\


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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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1R01EB027087-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

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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