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Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)

NCT00001248 · National Institutes of Health Clinical Center (CC)
In plain English

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Official title
Evaluation of Progression in Multiple Sclerosis by Magnetic Resonance Imaging (MRI)
About this study
Study Description: This study is primarily designed to examine the evolving natural history of multiple sclerosis (MS) and its mimickers, viewed through the window of neuroimaging (especially magnetic resonance imaging or MRI). After required baseline evaluation, follow-up study timepoints are driven by clinical standard-of-care, and data from clinically driven procedures may be analyzed for research. Optional research procedures may also be performed during these visits. Optional research-only visits may be scheduled to further investigate findings from the clinical visits. The same research procedures may be performed in healthy volunteers to assess whether the research findings are specific to the affected participant group. Objectives: To describe the evolving natural history of MS, viewed clinically, radiologically, and biologically, both prior to and after the introduction of increasingly effective disease modifying therapies (DMT). The protocol has three other important objectives: (1) screening prospective participants for selected NINDS Neuroimmunology Clinic trials; (2) studying healthy volunteers for comparison with affected participants and for development of new experimental technologies; and (3) comparing MS to other neurological diseases that share imaging or clinical features. Endpoints: The primary endpoint is the rate of change in the number of new white matter lesions per participant, indexed by the date of baseline evaluation.
Eligibility criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. One of the following: 1. Affected participant with either a diagnosis of MS based on currently accepted diagnostic criteria, or imaging or clinical abnormalities associated with MS. 2. Healthy volunteer. 2. Age \>=18 3. Able to give informed consent. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Contraindication to MRI at the time of initial enrollment (with the exception of pregnancy). 2. Unwilling to allow coded samples to be processed offsite or unwilling to have coded samples used in other studies.
Study design
Enrollment target: 3750 participants
Age groups: adult, older_adult
Timeline
Starts: 1992-07-23
Last updated: 2026-07-08
Primary outcomes
  • the rate of change in the number of new white matter lesions per participant (baseline vs. follow up visits)
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) · nih
Contacts & investigators
ContactJenifer E Dwyer · contact · jenifer.dwyer@nih.gov · (301) 496-3825
ContactDaniel S Reich, M.D. · contact · reichds@ninds.nih.gov · (301) 496-1801
InvestigatorDaniel S Reich, M.D. · principal_investigator, National Institute of Neurological Disorders and Stroke (NINDS)
All locations (1)
National Institutes of Health Clinical CenterRecruiting
Bethesda, Maryland, United States
Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS) · TrialPath