Multiple SclerosisNCT04415372
Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis
An observational study of Multiple Sclerosis and MS, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, MS
- What is being tested?
- MRI and Neuropsychological Testing
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2021to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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)
Who may be able to join
- Clinically definite MS
- Adult age 18 to 60
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Wisconsin, Madison
Madison, Wisconsin, 53705
About this study
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.
Read the 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
- Being tested
- MRI, Neuropsychological Testing
- Keywords
- Magnetic resonance imaging
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called Functional 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 TestingDiagnostic test
A comprehensive battery of neuropsychological tests will be administered to assess memory, new learning, spatial processing and higher executive function.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Impairment | Adults diagnosed with MS that have evidence of cognitive decline. Receives: Diagnostic Test: MRI; Diagnostic Test: Neuropsychological Testing | |
| No Cognitive Impairment | Adults diagnosed with MS that have no evidence of cognitive decline. Receives: Diagnostic Test: MRI; Diagnostic Test: Neuropsychological Testing | |
| Healthy Controls | Healthy adult volunteers will form a control group matched for age, gender, education, handedness Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
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.
Measured: 24 hours
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start19 Nov 2021
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Alexey Samsonov, PhD, Principal investigator, UW Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415372
- Sponsor's protocol ID
- 2020-0310
- Other IDs
- 1R01EB027087-01, A539300, SMPH/RADIOLOGY/RADIOLOGY, Protocol Version 4/8/2024
- Status last verified
- Apr 2026
- First submitted
- 29 May 2020
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macromolecular Imaging of White and Gray Matter Pathology in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04415372
- Acronym / sponsor ID
- 2020-0310
- Conditions
- Multiple Sclerosis, MS
- Keywords
- Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Impairment | – | Diagnostic Test: MRI, Diagnostic Test: Neuropsychological TestingAdults diagnosed with MS that have evidence of cognitive decline. |
| No Cognitive Impairment | – | Diagnostic Test: MRI, Diagnostic Test: Neuropsychological TestingAdults diagnosed with MS that have no evidence of cognitive decline. |
| Healthy Controls | – | Diagnostic Test: MRIHealthy adult volunteers will form a control group matched for age, gender, education, handedness |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (2 listed)
- Clinically definite MS
- Adult age 18 to 60
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: Functional MRIThe MRI protocol will include conventional testing for MS lesion detection and functional MR imaging to localize associated neurocognitive domains in each subject. | Diagnostic test | Cognitive Impairment, Healthy Controls, No Cognitive Impairment |
| Neuropsychological TestingA comprehensive battery of neuropsychological tests will be administered to assess memory, new learning, spatial processing and higher executive function. | Diagnostic test | Cognitive Impairment, No Cognitive Impairment |
Primary outcome
Measurement of macromolecular proton content (MPC) by Magnetic resonance imaging
Time frame: 24 hours
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexey Samsonov, PhD principal investigator
UW Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and MS, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of macromolecular proton content (MPC) by Magnetic resonance imaging (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.