NCT00001248

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

Recruiting now Last updated 14 April 2026

What this trial tests

trial in Multiple Sclerosis in 3,750 participants. Currently enrolling.

Timeline

23 July 1992

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	3,750
Start date	23 July 1992
Sites	1 location across United States

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 18 to 120, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Studies performed under 89-N-0045 are designed to examine the natural history of multiple sclerosis (MS) using MRI and immunological measures. In addition to studying the natural history of untreated patients, the natural history of patients receiving approved disease-modifying therapies of MS will be examined. In both cohorts of patients levels of disease activity on MRI will be compared with immunological characteristics in order to help identify disease mechanism. Patients with either definite MS (based either on clinical or combined clinical and MRI criteria) or with an initial presentation of neurological dysfunction consistent with MS will be studied longitudinally by MRI. Disease activity on MRI will be assessed using several MRI measures of disease activity including the number of contrast enhancing lesions, the overall burden of disease, brain atrophy and measures to assess axonal damage. Patients will be assessed clinically and correlations between immunological and genetic factors and disease activity as seen clinically or by MRI will be studied.

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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Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Persistent 7-tesla phase rim predicts poor outcome in new multiple sclerosis patient lesions.
   Absinta M, Sati P, Schindler M, Leibovitch EC, et al · · 2016 · cited 266× · PMID 27270171 · DOI 10.1172/jci86198
2. Identification of direct connections between the dura and the brain.
   Smyth LCD, Xu D, Okar SV, Dykstra T, et al · · 2024 · cited 182× · PMID 38326613 · DOI 10.1038/s41586-023-06993-7
3. 7T MRI Differentiates Remyelinated from Demyelinated Multiple Sclerosis Lesions.
   Kolb H, Absinta M, Beck ES, Ha SK, et al · · 2021 · cited 53× · PMID 34390015 · DOI 10.1002/ana.26194
4. Central Vein Sign Profile of Newly Developing Lesions in Multiple Sclerosis: A 3-Year Longitudinal Study.
   Al-Louzi O, Letchuman V, Manukyan S, Beck ES, et al · · 2022 · cited 29× · PMID 35027474 · DOI 10.1212/nxi.0000000000001120
5. Cervical and thoracic cord atrophy in multiple sclerosis phenotypes: Quantification and correlation with clinical disability.
   Mina Y, Azodi S, Dubuche T, Andrada F, et al · · 2021 · cited 19× · PMID 34215150 · DOI 10.1016/j.nicl.2021.102680
6. Highly Sensitive 3-Tesla Real Inversion Recovery MRI Detects Leptomeningeal Contrast Enhancement in Chronic Active Multiple Sclerosis.
   Okar SV, Dieckhaus H, Beck ES, Gaitán MI, et al · · 2024 · cited 15× · PMID 37493285 · DOI 10.1097/rli.0000000000001011
7. Imaging of brain barrier inflammation and brain fluid drainage in human neurological diseases.
   Okar SV, Fagiani F, Absinta M, Reich DS. · · 2024 · cited 11× · PMID 38212566 · DOI 10.1007/s00018-023-05073-3
8. Lesion size and shape in central vein sign assessment for multiple sclerosis diagnosis: An in vivo and postmortem MRI study.
   Al-Louzi O, Manukyan S, Donadieu M, Absinta M, et al · · 2022 · cited 11× · PMID 35674284 · DOI 10.1177/13524585221097560