Magnetic Resonance Imaging (MRI) is an advanced form of X-ray that uses magnetism to create pictures with excellent anatomical resolution. MRI is especially useful when studying the brain and nervous system.

One type of MRI is done after a drug called gadolinium is injected into the vein. Gadolinium does not usually crossover from the bloodstream into the brain. However, when it does cross it can be seen by MRI. Therefore, when gadolinium is detected by MRI it means there has been some disruption of the barrier that normally exists between the blood and the brain. Researchers believe that a change in the blood-brain barrier is the first step in the development of new MS lesions.

The overall goals of the study are to identify immunological processes that may contribute to the development of Multiple Sclerosis and to design specific therapies for the disease.

Condition
Multiple Sclerosis

Further Study Details: 

Expected Total Enrollment:  240

Studies performed under 89-N-0045 are designed to examine the natural history of multiple sclerosis (MS) using MRI. In addition to studying the natural history of untreated patients, the natural history of patients receiving approved therapies of MS will be examined. 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 studies.

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.

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:
Diagnosis of MS based on combined MRI and clinical crtieria OR, presenation with a clinically isolated syndrome consistent with MS and at least 2 abnormalities on MRI consistent with MS.
18-60 years of age
Not currently receiving therapy for MS
Able to give informed consent
EXCLUSION CRITERIA:
Diagnosis of neurological disease other than MS
Significant medical condition other than MS
Contraindication for MRI
Pregnancy

Maryland
      National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  890045; 89-N-0045
Record last reviewed:  March 29, 2004
Last Updated:  November 23, 2004
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001248
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08