Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis - Full Text View

Purpose

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.

Condition	Intervention
Multiple Sclerosis	Drug: standard gadolinium contrast

MedlinePlus related topics:

Multiple Sclerosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	100
Study Start Date:	April 1999

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.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of multiple sclerosis Relapsing-remitting defined as 2 exacerbations and a worsening of neurologic function over 1 day followed by at least 30 days of no progression OR Secondary-progressive defined as increase of at least 1.0 unit on Expanded Disability Status Scale (EDSS) in past 2 years with or without exacerbations

--Prior/Concurrent Therapy--

Biologic therapy: Prior interferon beta 1A, 1B, or glatiramer acetate No concurrent interferon beta 1A, 1B, or glatiramer acetate
Endocrine therapy: Concurrent oral and IV corticosteroids allowed

--Patient Characteristics--

Performance status: EDSS no greater than 7.0
Hematopoietic: No hematologic dysfunction including hemolytic anemia
Hepatic: No hepatic dysfunction
Renal: No renal dysfunction
Cardiovascular: No cardiac pacemaker
Other: Not pregnant or nursing Negative pregnancy test No intracranial clips, metal implants, or external clips within 10 mm of head No metal in eyes No known gadolinium texaphyrin allergy No known claustrophobia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006060

Locations


United States, New York
	New York University Medical Center
	New York, New York, United States, 10016

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Pennsylvania

Investigators


Study Chair:	Robert I. Grossman, MD	New York University School of Medicine

More Information

Study ID Numbers:	199/15245, UPSM-704-0, UPSM-070300, UPSM-NS-29029
First Received:	July 5, 2000
Last Updated:	August 18, 2006
ClinicalTrials.gov Identifier:	NCT00006060
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

multiple sclerosis

neurologic and psychiatric disorders

rare disease

Study placed in the following topic categories:

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

Mental Disorders

Rare Diseases

Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases

Sclerosis

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes

Immune System Diseases

Nervous System Diseases

ClinicalTrials.gov processed this record on July 08, 2008

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of Pennsylvania
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00006060