Magnetic Resonance Imaging to Detect Brain Damage in Patients With Multiple Sclerosis
An Exploratory Study on Detection of Cortical Damage in Patients With Multiple Sclerosis Using Magnetic Resonance Imaging
2 other identifiers
observational
94
1 country
1
Brief Summary
This study will determine whether magnetic resonance imaging (MRI) can detect damage to certain parts of the brain and analyze the thickness of the brain's outer surface in patients with multiple sclerosis. MRI is a diagnostic test that uses a strong magnetic field and radio waves to obtain images of body organs and tissues. It can sometimes permit diagnosis even before symptoms develop. MS is a disease of white matter, the fatty covering around the nerves in the brain and spinal cord. The nerves themselves are called gray matter. Damage to white matter impairs nerve function, leading to a variety of symptoms, such as weakness, vision problems, difficulty walking, paralysis, and others. MRI can detect some changes in white matter, but changes that may also appear in gray matter may be more difficult to find. This study will use new MRI techniques to try to identify gray matter damage in patients with MS. Healthy volunteers and people with MS or clinically isolated syndrome (an early stage of MS in which the patient has had just one of the problems MS can cause) who are between 18 and 55 years of age may be eligible for this study. Candidates are screened with a medical history and neurological examination, and blood and urine tests. Within one month of the screening evaluation, participants undergo MRI scanning on a standard 1.5 Tesla machine to confirm their health status. (The power of the MRI scanner is measured in Tesla; the higher the Tesla, the better the visualization.) For this procedure, the subject lies on a table that moves into the scanner (a narrow cylinder with a magnetic field), and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. During the procedure, a contrast agent called Gadolinium is injected into the blood stream to brighten the images. The test lasts about 2 hours, during which time the subject must lie still for up to a few minutes at a time. Within a month after the first MRI, participants repeat the test for a second time. The procedure is identical to the first scan, except a 3.0 Tesla machine is used.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 8, 2004
CompletedFirst Submitted
Initial submission to the registry
December 10, 2004
CompletedFirst Posted
Study publicly available on registry
December 10, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2011
CompletedJuly 2, 2017
September 28, 2011
December 10, 2004
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Diagnosis of clinically isolated syndrome or MS.
- Age between 18 and 55.
- EDSS between 0 and 6.5.
You may not qualify if:
- Presence of clinical relapse at the time of the enrollment or within the previous 3 months.
- Concomitant systemic disorder or central nervous system diseases of any kind or other related risk factors.
- Previous history of alcohol and substances abuse.
- Medical contraindications for MRI.
- Psychological contraindications for MRI.
- Pregnancy.
- Unable to provide informed consent.
- Age greater than 18 years.
- Systemic disorder or central nervous system diseases of any kind or other related risk factors.
- Previous history of alcohol and substances abuse.
- Medical contraindications for MRI.
- Psychological contraindications for MRI.
- Pregnancy.
- Unable to provide informed consent.
- Age greater than 18 years.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
McFarland HF. The emerging role of MRI in multiple sclerosis and the new diagnostic criteria. Mult Scler. 2002 Feb;8(1):71-2. doi: 10.1177/135245850200800114. No abstract available.
PMID: 11936491BACKGROUNDLi DK, Zhao G, Paty DW. T2 hyperintensities: findings and significance. Neuroimaging Clin N Am. 2000 Nov;10(4):717-38 ,ix.
PMID: 11359721BACKGROUNDHarris JO, Frank JA, Patronas N, McFarlin DE, McFarland HF. Serial gadolinium-enhanced magnetic resonance imaging scans in patients with early, relapsing-remitting multiple sclerosis: implications for clinical trials and natural history. Ann Neurol. 1991 May;29(5):548-55. doi: 10.1002/ana.410290515.
PMID: 1859184BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 10, 2004
First Posted
December 10, 2004
Study Start
December 8, 2004
Study Completion
September 28, 2011
Last Updated
July 2, 2017
Record last verified: 2011-09-28