Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 12:09 PM
Study NCT ID:
NCT00006060
Status:
UNKNOWN
Last Update Posted:
2009-03-12
First Post:
2000-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis
Sponsor:
National Center for Research Resources (NCRR)
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2009-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES: I. Determine by quantitative magnetic resonance imaging measurements the change in the total volume of brain parenchyma as well as its gray and white matter, T2 and enhanced T1 lesion volume, and the magnetization transfer ratio histogram parameters, and correlate these measurements with clinical measures of disability in patients with multiple sclerosis.
II. Measure the quantity of whole brain N-acetylaspartate in patients with multiple sclerosis and compare these values to those from age matched controls.
III. Determine the correlation between specific neuropsychological tests which assess global cognitive functioning and the quantitative measurements taken in these patients in this study.
II. Measure the quantity of whole brain N-acetylaspartate in patients with multiple sclerosis and compare these values to those from age matched controls.
III. Determine the correlation between specific neuropsychological tests which assess global cognitive functioning and the quantitative measurements taken in these patients in this study.
Detailed Description:
PROTOCOL OUTLINE:
Patients undergo magnetic resonance imaging and spectroscopy with standard gadolinium contrast followed by neuropsychological testing every 6 months for 5 years. An equal number of age and sex matched healthy patients act as a control group and undergo magnetic resonance imaging and spectroscopy without standard gadolinium contrast every 6 months for 5 years.
Patients undergo magnetic resonance imaging and spectroscopy with standard gadolinium contrast followed by neuropsychological testing every 6 months for 5 years. An equal number of age and sex matched healthy patients act as a control group and undergo magnetic resonance imaging and spectroscopy without standard gadolinium contrast every 6 months for 5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: