Natural History of Multiple Sclerosis and Its Mimickers

NCT02504840 | Completed

• 2 other identifiers: 15015815-N-0158
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Magnetic resonance imaging (MRI) has been used for decades to help diagnose and monitor neurological disorders like multiple sclerosis (MS). Researchers want to improve how MRI pictures are taken. They also want to learn more about using newer MRIs with stronger magnets to get better pictures than standard MRIs provide. Objectives: \- To collect data that will help researchers better understand MS and related diseases. Eligibility:

• Adults 18 and older with MS or MRI findings that appear similar to MS, or with other neurological diseases that may look or act like MS.
• Healthy adult volunteers. Design:
• Participants will be screened with a review of their medical records.
• Participants will have a baseline visit. It will include a physical exam, medical history, and neurological exam. They may have blood tests.
• The study will last indefinitely.
• Participants may have MRIs. Some MRIs may include a contrast dye. For this, a needle will be used to guide a thin plastic tube into an arm vein.
• Participants may have up to 2 lumbar punctures per year. Skin will be numbed and a needle inserted between back bones will remove fluid.
• Participants may give saliva samples and have an eye exam.
• Participants may have evoked potential tests. These measure how the nervous system responds to different types of stimulation. Participants may sit in front of a TV and watch pictures on the screen. Or they may wear earphones that make a clicking noise or static. Or they may get a small electrical shock that may tingle and cause a hand or foot twitch.
• Participants may have tests of strength, spasticity, sensations, balance, and/or walking.

Conditions

Neurologic Disorders; Healthy Volunteers; Multiple Sclerosis

Keywords

Multiple Sclerosis; Clinically Isolated Syndrome; CNS Inflammatory Demyelination; Radiologically Isolated Syndrome; Natural History

Outcome Measures

Primary Outcomes (1)

• Association between clinical status and research data

  Imaging measures will focus on features related to the central nervous system (CNS), particularly focal lesions. Clinical measures will include standard and established MS disability scales as well as quantitative measures related to function. Biological measures will include genotype, gene expression, proteomics, virological studies, and immunological profiling.

  over time

Study Arms (3)

healthy volunteers

healthy volunteers

patient controls

Participants with diseases that share features with MS.

patients with suspected or confirmed multiple sclerosis

Participants with definite, probable, or possible MS.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 1300 participants will be enrolled onto this open-ended thematic protocol. The following study populations will be included:- Participants with definite, probable, or possible MS. These participants either carry a diagnosis of MS, or else their referring clinicians are considering the diagnosis.-Participants with diseases that share imaging features with MS. These participants report clinical symptoms or prior MRI findings that could, in the best judgment of the investigators, be due to inflammatory demyelination of the central nervous system.- Healthy volunteers.-Withdrawals and dropouts will not be replaced.

You may qualify if:

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• One or more of the following:
• Diagnosis of MS, clinically isolated syndrome, or radiologically isolated syndrome.
• Presentation with clinical or neuroimaging findings that, in the best judgment of the investigators, are possibly consistent with central nervous system inflammatory demyelination.
• Healthy volunteer.
• Age greater than or equal to18.
• Able to participate in study procedures and provide high-quality clinical research data, in the best judgment of the investigators.
• Interest of the study investigators in performing one or more procedures under one or more of the substudies.

You may not qualify if:

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

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

Location

Related Publications (3)

• Gaitan MI, Shea CD, Evangelou IE, Stone RD, Fenton KM, Bielekova B, Massacesi L, Reich DS. Evolution of the blood-brain barrier in newly forming multiple sclerosis lesions. Ann Neurol. 2011 Jul;70(1):22-9. doi: 10.1002/ana.22472. Epub 2011 Jun 27.

  PMID: 21710622 BACKGROUND

• Jones BC, Nair G, Shea CD, Crainiceanu CM, Cortese IC, Reich DS. Quantification of multiple-sclerosis-related brain atrophy in two heterogeneous MRI datasets using mixed-effects modeling. Neuroimage Clin. 2013 Aug 13;3:171-9. doi: 10.1016/j.nicl.2013.08.001. eCollection 2013.

  PMID: 24179861 BACKGROUND

• McFarland HF, Frank JA, Albert PS, Smith ME, Martin R, Harris JO, Patronas N, Maloni H, McFarlin DE. Using gadolinium-enhanced magnetic resonance imaging lesions to monitor disease activity in multiple sclerosis. Ann Neurol. 1992 Dec;32(6):758-66. doi: 10.1002/ana.410320609.

  PMID: 1471866 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Nervous System Diseases; Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel S Reich, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 22, 2015
• Study Start: July 23, 2015
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

US (1)