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Enrolling by invitation NCT04415372

Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

— Observational Multiple Sclerosis MS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI, Neuropsychological Testing.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, MS. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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 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.

Primary outcome measures

  • Measurement of macromolecular proton content (MPC) by Magnetic resonance imaging [Time frame: 24 hours]
Secondary outcome measures (2)
  • Neurocognitive performance as measured by Minimal Assessment of Cognitive Function in MS (MACFIMS) battery of neuropsychological (NP) tests [Time frame: 24 hours]
  • Neurocognitive performance as measured by the Montreal Cognitive Assessment (MoCA) score [Time frame: 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • University of Wisconsin, Madison — Madison

Identifiers

NCT: NCT04415372 · 2020-0310 · 1R01EB027087-01 · A539300 · SMPH/RADIOLOGY/RADIOLOGY · Protocol Version 4/8/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗