Clinical trial NCT04415372: Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis
Official title: Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Multiple Sclerosis
MS
Keywords: Magnetic resonance imaging
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2020-06-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults diagnosed with MS both with and without evidence of cognitive impairment.

Healthy controls will be recruited from the MRI Volunteer Database (2017-0004, PI: Reeder)

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.

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

Primary outcomes:
measure: Measurement of macromolecular proton content (MPC) by Magnetic resonance imaging
timeFrame: 24 hours
Secondary outcomes:
measure: Neurocognitive performance as measured by Minimal Assessment of Cognitive Function in MS (MACFIMS) battery of neuropsychological (NP) tests
timeFrame: 24 hours
measure: Neurocognitive performance as measured by the Montreal Cognitive Assessment (MoCA) score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
Study officials:
affiliation: UW Madison
name: Alexey Samsonov, PhD
role: PRINCIPAL_INVESTIGATOR
References: