NCT04415372

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Nov 2021Apr 2027

First Submitted

Initial submission to the registry

May 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 19, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

5.4 years

First QC Date

May 29, 2020

Last Update Submit

April 22, 2026

Conditions

MSMultiple Sclerosis

Keywords

Magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Neurocognitive performance as measured by Minimal Assessment of Cognitive Function in MS (MACFIMS) battery of neuropsychological (NP) tests

    24 hours

  • Neurocognitive performance as measured by the Montreal Cognitive Assessment (MoCA) score

    24 hours

Study Arms (3)

Cognitive Impairment

Adults diagnosed with MS that have evidence of cognitive decline.

Diagnostic Test: MRIDiagnostic Test: Neuropsychological Testing

No Cognitive Impairment

Adults diagnosed with MS that have no evidence of cognitive decline.

Diagnostic Test: MRIDiagnostic Test: Neuropsychological Testing

Healthy Controls

Healthy adult volunteers will form a control group matched for age, gender, education, handedness

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_TEST

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

Also known as: Functional MRI
Cognitive ImpairmentHealthy ControlsNo Cognitive Impairment
Neuropsychological TestingDIAGNOSTIC_TEST

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

Cognitive ImpairmentNo Cognitive Impairment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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)

You may qualify if:

  • Clinically definite MS
  • Adult age 18 to 60

You may not qualify if:

  • 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.\\
  • history of alcohol/drug abuse
  • history of migraines
  • developmental or learning disability/attention-deficit/hyperactivity disorder
  • currently pregnant/breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin, Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Alexey Samsonov, PhD

    UW Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 4, 2020

Study Start

November 19, 2021

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)