This study is currently recruiting patients.

http://clinicaltrials.gov/ct/gui/c/w1r/screen/ResultScreen/action/GetStudy?order=1&xml_file_id=xmlfiles%2FWMCC__NCT00001248.xml%40csdb

Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

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

Study Type:

Natural History

Official Title:

Evaluation of Progression in Multiple Sclerosis by Magnetic Resonance Imaging (MRI)

Further Study Details:

Efforts to measure progression of disease activity in multiple sclerosis (MS) have been difficult and this problem has become increasingly evident in the assessment of clinical changes in patients involved in clinical trials. Recent evidence has suggested that MRI, and particularly MRI following the administration of gadolinium to demonstrate changes in blood-brain barrier, may be an effective means for monitoring disease activity. This study will examine the use of MRI to evaluate disease activity in MS over time. MRI findings will be correlated with clinical status. A small number of patients will also be studied by magnetization transfer (MT) along with MRI in an effort to identify the metabolic changes occurring in acute lesions of MS. The effect of interferon beta-Ib, now approved for use in patients with relapsing-remitting MS, will be studied for its effect on disease activity as measured by MRI. Immunological studies will be done in parallel with the MRI evaluation.

Eligibility

Genders Eligible for Study:

Both

Criteria:

Subjects must have a laboratory supported definite MS or a relapsing-remitting course.
 
Location and Contact Information:

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

Recruiting
 
PRPL  1-800-411-1222
prpl@mail.cc.nih.gov

More Information

Detailed Web Page (http://clinicalstudies.info.nih.gov/detail/A_1989-N-0045.html)

Publications

Tresley. 1997. Clinical safety of serial monthly administrations of gadopentetate dimeglumine in patients with multiple sclerosis: implications for natural history and early-phase treatment trials, Neurology, Vol. 48, p. 832

Calabresi. 1997. Interferon beta results in immediate reduction of contrast-enhanced MRI lesions in multiple sclerosis patients followed by weekly MRI, Neurology, Vol. 48, p. 1446

Calabresi. 1997. Increases insoluble VCAM-1 correlate with a decrease in MRI lesions in multiple sclerosis treated with interferon beta-1b, Ann Neurol, Vol. 41, p. 669

Study ID Numbers  89-N-0045
NLM Identifier  NCT00001248
Date study started March 13, 1989
Recruitment status verified  April 19, 2001
Last Updated  April 19, 2001