NCT04415372

Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Sclerosis
• MS

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI	The MRI protocol will include conventional testing for MS lesion detection and functional MR imaging to localize associated neurocognitive domains in each subject.
DIAGNOSTIC_TEST	Neuropsychological Testing	A comprehensive battery of neuropsychological tests will be administered to assess memory, new learning, spatial processing and higher executive function.

Timeline

• Start date: 2021-11-19
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2020-06-04
• Last updated: 2025-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study