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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001248
First received: November 3, 1999
Last updated: July 10, 2014
Last verified: September 2013

November 3, 1999
July 10, 2014
March 1989
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Complete list of historical versions of study NCT00001248 on ClinicalTrials.gov Archive Site
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Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)
Evaluation of Progression in Multiple Sclerosis by Magnetic Resonance Imaging (MRI)

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.

Studies performed under 89-N-0045 are primarily designed to examine the natural history of multiple sclerosis (MS) and its mimickers, viewed through the window of imaging (especially magnetic resonance imaging or MRI). The protocol has four other important objectives: (1) Screening prospective participants in selected Neuroimmunology Branch clinical trials; (2) Performing studies to help define the mechanism of action and cause of side effects of disease modifying therapies (DMT); (3) Studying healthy volunteers for comparison with patients and for development of new experimental technologies; and (4) Comparing MS to other neurological diseases that share imaging features.

Disease activity on MRI will be assessed using several MRI measures, focusing on the number of new on-study lesions but also including the number of contrast-enhancing lesions, the total number of MRI-visible lesions, brain atrophy, and more recently defined MRI measures of tissue damage, such as quantitative magnetic relaxation mapping, diffusion-weighted imaging (DWI), magnetization transfer imaging (MTI), and MR spectroscopy (MRS). Additionally, participants will be assessed with other imaging modalities, specifically optical coherence tomography (OCT) and fluorescein angiography of the eye, and they will also be studied clinically and with neurophysiologic tests.

In order to obtain comparative data for proper interpretation of the results in MS, two control cohorts one consisting of patients, the other of healthy volunteers will be studied. The patient control cohort will have three subcohorts: (1) patients with other disorders who are receiving DMT used in MS and are experiencing similar side effects (e.g. progressive multifocal encephalopathy (PML) in patients with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA)), (2) patients who are receiving DMT not used in MS but in whom MS-like illness is suspected (e.g. TNF-alpha inhibitors in patients with rheumatological diseases) and (3) patients with neurodegenerative diseases that may share pathophysiological processes with MS patients (e.g. oxidative stress in patients with Parkinson s disease or mitochondrial dysfunction in patients with mitochondrial diseases) and who do not qualify for the enrollment to the 09-N-0032 protocol. Enrollment of patients with different diseases who are experiencing identical side effects on DMTs as those studied in MS cohort will help to answer the question of whether the identified mechanism of action of the side effect is MS specific or generalizable. The other neurological disease cohort will provide data to assess the specificity of the MRI findings in the MS cohort.

Observational
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Multiple Sclerosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
540
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  • INCLUSION CRITERIA:

Inclusion criteria for all populations:

  • Diagnosis of MS based on combined MRI and clinical criteria (Polman et al., 2005) OR presentation with a clinically isolated syndrome consistent with MS and at least two abnormalities on MRI consistent with MS OR diagnosis of another neurological disease of the CNS (see Section 6.1.2) OR patients with other diseases who are receiving identical DMTs as the MS cohort OR patients who acquire an MS-like disease while receiving immunomodulatory agents for a different indication.
  • For patients with neuroimmunological disorders, treatment with any available immunomodulatory therapy.
  • Age greater than or equal to 18.
  • Able to give informed consent.

EXCLUSION CRITERIA:

Exclusion criteria for all cohorts:

  • Contraindication to MRI.
  • Fulfills inclusion criteria for 09-N-0032 protocol, i.e. any untreated neuroimmunological or CNS white matter disease that requires diagnostic work-up.
  • Pregnancy.
  • Unwilling to allow coded samples to be processed offsite or unwilling to have coded samples used in other studies.
Both
18 Years to 70 Years
Yes
Contact: Rosalind Hayden, R.N. (301) 827-9002 ebingerre@mail.nih.gov
Contact: Daniel S Reich, M.D. (301) 496-1801 reichds@ninds.nih.gov
United States
 
NCT00001248
890045, 89-N-0045
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National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Daniel S Reich, M.D. National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP