Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT04415372

Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin, Madison

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

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.

Other names: Functional MRI

Neuropsychological testing

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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.

  2. Neurocognitive performance as measured by the Montreal Cognitive Assessment (MoCA) score

    Time frame: 24 hours

    Neurocognitive performance will be measured by Montreal Cognitive Assessment. MoCA scores range from 0 to 30, higher values corresponding to better cognitive performances.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2020
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.