Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04415372
• Other study ID #: 2020-0310
• Secondary ID: 1R01EB027087-01A
• Status: Enrolling by invitation
• Start date: November 19, 2021
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: April 2027
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• MS
• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin, Madison	Madison	Wisconsin

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of macromolecular proton content (MPC) by Magnetic resonance imaging	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.	24 hours
Secondary	Neurocognitive performance as measured by Minimal Assessment of Cognitive Function in MS (MACFIMS) battery of neuropsychological (NP) tests	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.	24 hours
Secondary	Neurocognitive performance as measured by the Montreal Cognitive Assessment (MoCA) score	Neurocognitive performance will be measured by Montreal Cognitive Assessment. MoCA scores range from 0 to 30, higher values corresponding to better cognitive performances.	24 hours