Skip to content

Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04415372
Enrollment
75
Registered
2020-06-04
Start date
2021-11-19
Completion date
2027-04-01
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS, Multiple Sclerosis

Keywords

Magnetic resonance imaging

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTMRI

The MRI protocol will include conventional testing for MS lesion detection and functional MR imaging to localize associated neurocognitive domains in each subject.

DIAGNOSTIC_TESTNeuropsychological Testing

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

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
CollaboratorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.\\

Design outcomes

Primary

MeasureTime frameDescription
Measurement of macromolecular proton content (MPC) by Magnetic resonance imaging24 hoursMacromolecular 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

MeasureTime frameDescription
Neurocognitive performance as measured by Minimal Assessment of Cognitive Function in MS (MACFIMS) battery of neuropsychological (NP) tests24 hoursThe 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.
Neurocognitive performance as measured by the Montreal Cognitive Assessment (MoCA) score24 hoursNeurocognitive performance will be measured by Montreal Cognitive Assessment. MoCA scores range from 0 to 30, higher values corresponding to better cognitive performances.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlexey Samsonov, PhD

UW Madison

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026