Recruiting

Natural History Evaluation of Multiple Sclerosis Through Neuroimaging

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Study Aim

This observational study aims to determine the rate of change in the number of new white matter lesions in individuals with Multiple Sclerosis, helping to understand how disease activity has evolved with the advent of more effective therapies.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Autoimmune Diseases+4

+ Demyelinating Diseases

+ Immune System Diseases

From 18 to 120 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: July 1992
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Study ContactJenifer E DwyerMore contacts
Last updated: July 8, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 23, 1992

Actual date on which the first participant was enrolled.

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.

NCT00001248
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Study ContactJenifer E DwyerMore contacts
Last updated: July 8, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3750 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDemyelinating DiseasesImmune System DiseasesNervous System DiseasesAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNSMultiple Sclerosis

Criteria

3 inclusion criteria required to participate
Affected participant with either a diagnosis of MS based on currently accepted diagnostic criteria, or imaging or clinical abnormalities associated with MS

Age >= 18

Healthy volunteer

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center