Pathological Basis of MRI Signal Changes in Multiple Sclerosis

NCT02659956 | Recruiting

• 2 other identifiers: 16005516-N-0055
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Multiple sclerosis (MS) is a disease that damages the central nervous system (brain and spinal cord). This leads to increased physical disability over time. The disease is lifelong once it begins. Researchers want to learn more about MS s stages and follow them until a person s death. Objective: To understand how the physical and clinical signs of MS relate to its changes over time. Eligibility: Adults age 18 or older with MS or a disease of the brain and spinal cord that may act like MS. Design: Participants will have a medical history and a complete neurological exam. They may have timed tests of neurological function, such as a 25-foot walk and a 9-hole peg test. Participants will have multi-day visits about once a year. Participants will have blood drawn. Participants may have a brain magnetic resonance imaging (MRI) scan. They may also have an MRI of the spinal cord. They may get a contrast agent (dye) injected into a tube in an arm vein. During the MRI, participants will lie on a table that slides in and out of a metal cylinder. Participants will have the thickness of their retina measured using optical coherence tomography. A camera on top of a table uses lasers. Participants will look through a lens and follow instructions. Eye drops may be used to dilate the pupils. Participants will chew on a piece of sterile cotton for 1 minute to collect saliva. Participants agree to have an autopsy at the time of their death and to donate some of their organs to research, such as the brain and spinal cord.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Longitudinal Prospective Follow-Up; Natural History

Outcome Measures

Primary Outcomes (1)

• Correlation among in vivo imaging, postmortem imaging, and pathological characteristics of individual areas of tissue damage ("lesions") in the brain, spinal cord, and retinas.

  Correlation among in vivo imaging, postmortem imaging, and pathological characteristics of individual areas of tissue damage ( lesions ) in the brain, spinal cord, and retinas. Priority will be given to measures of myelination, axonal preservation, inflammation, and astrogliosis, as judged primarily by histological stains and immunohistochemistry.

  annual visits

Study Arms (3)

Individuals without known CNS disease

Family members of patient participants

Patient controls

A target population of 100 patient controls will also be enrolled. These individuals will have diseases that share clinical, imaging, or biological features with MS.

Patients with multiple sclerosis

Up to 250 adults (age \>= 18) with MS, diagnosed by applicable consensus criteria and by the best judgment of the investigators at the time of enrollment.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary clinical

You may qualify if:

• Diagnosis of MS according to consensus criteria at the time of enrollment OR diagnosis of a disease that shares clinical, imaging, or biological features with MS OR individuals without known CNS disease.
• Age greater than or equal to 18.
• Able to participate in study procedures and provide high-quality clinical research data (for example, prior MRI scans show ability to tolerate the MRI scan with minimal motion artifact).
• Willing to return to NIH for follow-up visits approximately annually (or every 5 years for non-CNS controls) until the time of autopsy. Note: participants who become too sick to return to NIH will not be removed from the study.
• Willing to undergo autopsy with donation of at least the brain, spinal cord, and retinas.
• Able to provide informed consent at the time of initial study enrollment and willing to appoint a Durable Power of Attorney (DPA) if an advanced directive is not already in place.
• Except for non-CNS controls, simultaneously participating in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry.
• Eligible NIH employees and staff may participate.

You may not qualify if:

• Unwilling to allow sharing and/or use in future studies of coded samples and data that are collected for this study.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• Absinta M, Nair G, Filippi M, Ray-Chaudhury A, Reyes-Mantilla MI, Pardo CA, Reich DS. Postmortem magnetic resonance imaging to guide the pathologic cut: individualized, 3-dimensionally printed cutting boxes for fixed brains. J Neuropathol Exp Neurol. 2014 Aug;73(8):780-8. doi: 10.1097/NEN.0000000000000096.

  PMID: 25007244 BACKGROUND

• Absinta M, Vuolo L, Rao A, Nair G, Sati P, Cortese IC, Ohayon J, Fenton K, Reyes-Mantilla MI, Maric D, Calabresi PA, Butman JA, Pardo CA, Reich DS. Gadolinium-based MRI characterization of leptomeningeal inflammation in multiple sclerosis. Neurology. 2015 Jul 7;85(1):18-28. doi: 10.1212/WNL.0000000000001587. Epub 2015 Apr 17.

  PMID: 25888557 BACKGROUND

• Maggi P, Macri SM, Gaitan MI, Leibovitch E, Wholer JE, Knight HL, Ellis M, Wu T, Silva AC, Massacesi L, Jacobson S, Westmoreland S, Reich DS. The formation of inflammatory demyelinated lesions in cerebral white matter. Ann Neurol. 2014 Oct;76(4):594-608. doi: 10.1002/ana.24242. Epub 2014 Aug 21.

  PMID: 25088017 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Daniel S Reich, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenifer E Dwyer

CONTACT

(301) 496-3825; jenifer.dwyer@nih.gov

Daniel S Reich, M.D.

CONTACT

(301) 496-1801; reichds@ninds.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 21, 2016
• Study Start: April 7, 2016
• Primary Completion (Estimated): February 26, 2080
• Study Completion (Estimated): February 26, 2080
• Last Updated: May 11, 2026

Record last verified: 2026-05-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)