We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001248
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

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.


Condition or disease
Multiple Sclerosis

Detailed Description:

Studies performed under 89-N-0045 are 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). The protocol has four other important objectives: (1) Screening prospective participants for selected NINDS Neuroimmunology Clinic 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.

To the extent possible, scheduled testing performed under this protocol will coincide with standard-of-care evaluations for diagnosis and longitudinal clinical management, thereby reducing the burden of research participation by participants. Such testing may involve state-of-the-art research methods. Additional pure-research visits may be scheduled to further investigate findings observed on scheduled visits and/or outside studies.

Disease activity on MRI will be assessed using several MRI measures, including the detection of new on-study lesions, quantification of contrast-enhancing lesions, the total number and/or volume of MRI-visible lesions, brain volume and brain volume change, and more advanced MRI measures of tissue damage, such as quantitative magnetic relaxation mapping, diffusion-weighted imaging (DWI), magnetization transfer imaging (MTI), and MR spectroscopy (MRS). Participants may be assessed with other imaging modalities, including optical coherence tomography (OCT), and they will be asked to provide research samples (generally blood, but also saliva and cerebrospinal fluid) and be studied clinically.

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 include patients with other CNS diseases that may share pathophysiological processes with MS patients (e.g. other inflammatory conditions of the central nervous system, mitochondrial disorders, leukodystrophies, neurodegenerative diseases that may cause axonal loss or oxidative stress, or cerebral small vessel disease). Enrollment of these control patient populations will help to answer the question of whether the identified MRI findings and/or pathophysiological mechanisms are MS-specific or generalizable.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Progression in Multiple Sclerosis by Magnetic Resonance Imaging (MRI)
Actual Study Start Date : July 23, 1992

Resource links provided by the National Library of Medicine


Group/Cohort
healthy volunteers
Healthy volunteers for technique development and comparison with the patient populations.
MS/CIS/RIS population
Patients with a diagnosis of MS or who have typical imaging abnormalities associated with MS.
Non-MS comparison population
Patients with disorders of the CNS, to include patients with diseases that share mechanisms of tissue damage with MS



Primary Outcome Measures :
  1. the rate of change in the number of new white matter lesions per participant [ Time Frame: baseline vs. follow up visits ]
    The primary outcome, which is designed to determine how MS disease activity has changed with the advent of ever-more-effective disease-modifying therapy, is the rate of change in the number of new white matter lesions per participant, indexed by the date of baseline evaluation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
-MS/CIS/RIS population-Patients with a diagnosis of MS or who have typical imaging abnormalities associated with MS.-Non-MS comparison populations-Patients with disorders of the CNS, to include patients with diseases that share mechanisms of tissue damage with MS, such as mitochondrial disorders, leukodystrophies, neurodegenerative diseases that may cause axonal loss or oxidative stress, and chronic small vessel disease.-Healthy volunteers-Healthy volunteers for technique development and comparison with the patient populations.
Criteria
  • INCLUSION CRITERIA:
  • One of the following:

    • Diagnosis of MS or clinically isolated syndrome based on currently accepted diagnostic criteria.
    • Presentation with neuroimaging features consistent with MS.
    • Diagnosis of another disease of the CNS
    • Healthy volunteer.
  • Age greater than or equal to 18.
  • Able to give informed consent.

NIH employees are eligible to participate.

EXCLUSION CRITERIA:

  • Contraindication to MRI.
  • Pregnancy.
  • Unwilling to allow coded samples to be processed offsite or unwilling to have coded samples used in other studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001248


Contacts
Layout table for location contacts
Contact: Jenifer E Dwyer (301) 496-3825 jenifer.dwyer@nih.gov
Contact: Daniel S Reich, M.D. (301) 496-1801 reichds@ninds.nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Layout table for investigator information
Principal Investigator: Daniel S Reich, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00001248    
Other Study ID Numbers: 890045
89-N-0045
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: October 18, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: .This is a natural history, not a clinical trial, therefore we are not obligated to provide a data sharing statement.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Multiple Sclerosis
MRI (Magnetic Resonance Imaging)
Natural History
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases