NCT00099307

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2004

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

December 10, 2004

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2011

Completed
Last Updated

July 2, 2017

Status Verified

September 28, 2011

First QC Date

December 10, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

White MatterGrey MatterBrainDisabilityLesionsMultiple SclerosisMSHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 11936491BACKGROUND
  • Li DK, Zhao G, Paty DW. T2 hyperintensities: findings and significance. Neuroimaging Clin N Am. 2000 Nov;10(4):717-38 ,ix.

    PMID: 11359721BACKGROUND
  • Harris 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

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

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

Locations