NIH Clinical Research Studies

Protocol Number: 05-N-0039

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Title:
An Exploratory Study on Detection of Cortical Damage in Patients with Multiple Sclerosis Using Magnetic Resonance Imaging
Number:
05-N-0039
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.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA - MULTIPLE SCLEROSIS PATIENTS:

Diagnosis of clinically isolated syndrome or MS.

Age between 18 and 55.

EDSS between 0 and 6.5.

EXCLUSION CRITERIA - MULTIPLE SCLEROSIS PATIENTS:

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.

INCLUSION CRITERIA - HEALTHY VOLUNTEERS:

Age greater than 18 years.

EXCLUSION CRITERIA - HEALTHY VOLUNTEERS:

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.

INCLUSION CRITERIA - STROKE PATIENTS:

Age greater than 18 years.

Pure motor hemiparesis secondary to a first and single acute ischemic infarct localized in the white matter of the pyramidal tract (confirmation and location stroke by MRI).

No other major diseases of the central nervous system or neurological signs.

No other visible MRI lesions of the corticospinal tract on T2-weighted images (e.g., patients with white matter lesions on tracts not connected with the pyramidal tract and clinically silent will not be excluded).

EXCLUSION CRITERIA - STROKE PATIENTS:

Stroke onset less than 3 months prior to the study enrollment.

Previous history of alcohol and substances abuse.

Medical contraindications for MRI.

Contraindications for MRI.

Critical stenosis of either carotids or vertebrobasilar artery as demonstrated by a Transcranial Doppler.

Pregnancy.

Unable to provide informed consent.

Special Instructions:
Currently Not Provided
Keywords:
White Matter
Grey Matter
Brain
Disability
Lesions
Recruitment Keyword(s):
Multiple Sclerosis
MS
Healthy Volunteer
HV
Condition(s):
Multiple Sclerosis
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Neurological Disorders and Stroke

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
McFarland HF. The emerging role of MRI in multiple sclerosis and the new diagnostic criteria. Mult Scler. 2002 Feb;8(1):71-2. Review. No abstract available.

Li DK, Zhao G, Paty DW. T2 hyperintensities: findings and significance. Neuroimaging Clin N Am. 2000 Nov;10(4):717-38 ,ix. Review.

Harris JO, et al. 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.

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