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Magnetic Resonance Imaging to Detect Brain Damage in Patients With Multiple Sclerosis

This study has been completed.
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: December 10, 2004
Last updated: January 24, 2017
Last verified: September 28, 2011

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.

Multiple Sclerosis

Study Type: Observational
Official Title: An Exploratory Study on Detection of Cortical Damage in Patients With Multiple Sclerosis Using Magnetic Resonance Imaging

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 94
Study Start Date: December 8, 2004
Estimated Study Completion Date: September 28, 2011
Detailed Description:

OBJECTIVE: Detection of cortical lesions in patients with multiple sclerosis (MS) using magnetic resonance imaging (MRI) is challenging. Their identification might provide more insight in explaining the level of disability in patients with MS.

Primary aim of the present study is identifying cortical lesions in patients with MS using MRI. As a secondary aim, correlation between cortical lesions presence and clinical disability score (i.e. Expanded Disability Status Score or EDSS scale) will be analyzed. Tertiary aims will be provided by the relationships between the presence of cortical lesions and reduction in cortical thickness and extent of remote white matter disease pathology. Additionally, the role of white matter lesions in causing remote pathology will be studied. To better characterize this damage, patients with previous stroke, presenting with a single lesion on the pyramidal tract will be enrolled and diffusion-derived indices of white matter remote tracts will be computed.

STUDY POPULATION: Fifty patients with definite MS or with a single attack and an MRI suggestive of MS (i.e., clinically isolated syndrome) according to McDonald criteria, and 55 healthy volunteers will be enrolled. Fifteen patients with previous ischemic stroke and 15 age- and gender-matched healthy volunteers will also be enrolled.

DESIGN: After a clinical evaluation and an MRI at 1.5 Tesla, each individual will be imaged once at 3.0 Tesla scan. Clinical MRI before and within 15 minutes after contrast injection will be obtained in each patient at both 1.5 and 3 Tesla scans. In addition, 3 spoiled gradient-echo sequence, diffusion tensor images and double inversion recovery sequences will be acquired on the 3 Tesla MRI. Some healthy volunteers (up to 15) and patients (up to 15) will be required to be imaged twice on the 3T magnet as to optimize the sequences of this study. Additionally, 20 patients in whom cortical lesions will be identified using the above-mentioned techniques and 20 healthy volunteers will undergo brain perfusion MRIs. This may represent the third 3T MRI for the former in some instances.

OUTCOME MEASURES: In MS patients, the number of cortical lesions will be computed. The EDSS score will serve for investigating the relationship between cortical lesions and clinical disability. Effect of cortical or white matter lesions in causing remote degeneration will be studied using diffusion tensor and magnetization transfer imaging in patients with both stroke and MS.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Diagnosis of clinically isolated syndrome or MS.

Age between 18 and 55.

EDSS between 0 and 6.5.


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.


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.


Unable to provide informed consent.


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).


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.


Unable to provide informed consent.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00099307

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Publications: Identifier: NCT00099307     History of Changes
Other Study ID Numbers: 050039
Study First Received: December 10, 2004
Last Updated: January 24, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
White Matter
Grey Matter
Multiple Sclerosis
Healthy Volunteer

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases processed this record on April 28, 2017