Recruiting

Diagnostic Study

Sponsor:

National Center for Research Resources (NCRR)

Code:

NCT00006060

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 20 - 70

Healthy Volunteers: Accepted

Interventions

standard gadolinium contrast

Study Details

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.

Conditions

Multiple Sclerosis

Study ID

NCT00006060

Start date

Apr, 1999

Status verified date

Mar, 2009

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Interventions and Outcome Measures

Interventions

standard gadolinium contrast

Central Contacts and Locations

Central contacts

Robert I. Grossman, MD

212-263-3269

Locations

New York University Medical Center

Recruiting

New York, New York, United States, 10016

Contacts

Lois J. Mannon, BSRT, (MR) (R) CCRC

212-263-3783lois.mannon@med.nyu.edu

Principal Investigator:

Robert I. Grossman, MD

More Information

Sponsor

National Center for Research Resources (NCRR)

Last update posted

Mar 12, 2009

Last verified

Mar, 2009

Keywords

  • multiple sclerosis
  • neurologic and psychiatric disorders
  • rare disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Center for Research Resources (NCRR) on 2009-03-12.