Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)
NCT ID: NCT00001248
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3750 participants
OBSERVATIONAL
1992-07-23
Brief Summary
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A second cohort of patients starting the use of approved therapy will also be examined. Patients referred to NIH prior to beginning approved therapy will be assessed with a series of three monthly MRIs to determine the level of pretreatment disease activity. After beginning approved therapy under the direction of their private physician, patients will be followed similarly to the natural history cohort. Immunological and genetic findings will be accessed before and during therapy in order to help establish the mechanisms of action of the therapies and to identify mechanisms accounting for either a response or lack of response to therapy. Part of the collected samples willl be cryopreserved to provide respository for further studies focusing on detection of biomarkers indicative of disease state, disease stage or repsonse to therapies.
Additionally, a cohort of normal volunteers will be studied. The studies in the normal volunteers will be used to establish the most appropriate imaging sequences for studying normal white matter in MS patients using magnetization transfer (MT) imaging sequences for studying normal white matter in MS patients using magnetization transfer (MT) imaging and to provide normative immunological measures.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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healthy volunteers
Healthy volunteers for technique development and comparison with the patient populations.
No interventions assigned to this group
MS/CIS/RIS population
Patients with a diagnosis of MS or who have typical imaging abnormalities associated with MS.
No interventions assigned to this group
Non-MS comparison population
Patients with disorders of the CNS, to include patients with diseases that share mechanisms of tissue damage with MS
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
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.
18 Years
120 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Responsible Party
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Principal Investigators
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Daniel S Reich, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Role: primary
References
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Tresley RM, Stone LA, Fields N, Maloni H, McFarland H, Frank JA. Clinical safety of serial monthly administrations of gadopentetate dimeglumine in patients with multiple sclerosis: implications for natural history and early-phase treatment trials. Neurology. 1997 Apr;48(4):832-5. doi: 10.1212/wnl.48.4.832.
Calabresi PA, Stone LA, Bash CN, Frank JA, McFarland HF. Interferon beta results in immediate reduction of contrast-enhanced MRI lesions in multiple sclerosis patients followed by weekly MRI. Neurology. 1997 May;48(5):1446-8. doi: 10.1212/wnl.48.5.1446.
Calabresi PA, Tranquill LR, Dambrosia JM, Stone LA, Maloni H, Bash CN, Frank JA, McFarland HF. Increases in soluble VCAM-1 correlate with a decrease in MRI lesions in multiple sclerosis treated with interferon beta-1b. Ann Neurol. 1997 May;41(5):669-74. doi: 10.1002/ana.410410517.
Al-Louzi O, Letchuman V, Manukyan S, Beck ES, Roy S, Ohayon J, Pham DL, Cortese I, Sati P, Reich DS. Central Vein Sign Profile of Newly Developing Lesions in Multiple Sclerosis: A 3-Year Longitudinal Study. Neurol Neuroimmunol Neuroinflamm. 2022 Jan 13;9(2):e1120. doi: 10.1212/NXI.0000000000001120. Print 2022 Mar.
Absinta M, Sati P, Schindler M, Leibovitch EC, Ohayon J, Wu T, Meani A, Filippi M, Jacobson S, Cortese IC, Reich DS. Persistent 7-tesla phase rim predicts poor outcome in new multiple sclerosis patient lesions. J Clin Invest. 2016 Jul 1;126(7):2597-609. doi: 10.1172/JCI86198. Epub 2016 Jun 6.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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89-N-0045
Identifier Type: -
Identifier Source: secondary_id
890045
Identifier Type: -
Identifier Source: org_study_id
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