Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01226654
First received: October 20, 2010
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

The central hypothesis of this protocol is that neuronal death (relected primarily by gray matter volume loss) resulting from demyelination and inflammation-induced axonotomy (rather than myelin loss per se) is the primary factor in induction and progression of physical and neurocognitive disability in patients with multiple sclerosis.


Condition Intervention
Multiple Sclerosis
Other: Magnetic Resonance Imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quantitative MR Imaging and Proton Spectroscopy in MS

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Assess the MS lesions using Magnetization transfer ratio histogram parameters and compare it to total brain parenchymal volume [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    1) Lesions will be assessed by measuring T2 and T1 enhanced lesion volumes and magnetization transfer ratio histogram parameters (MTRHP) in patients with relapsing-remitting and secondary-progressive disease. This data will be correlated to total brain parenchymal volume as well as identifying the effect of MS lesions on the gray and white matter, volumetric disability, including Kurtzke Expanded Disability Status Scale (EDSS) and a specific battery of neuropsychological tests


Secondary Outcome Measures:
  • Quantitative analysis of whole brain N-acetylaspartate (WBNAA) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Quantitative analysis of whole brain N-acetylaspartate (WBNAA), a reproducible measure of viable neuron number, using 1H MRS and compare the results to age-matched controls over duration of 5 years


Estimated Enrollment: 160
Study Start Date: August 1991
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: other Other: Magnetic Resonance Imaging
Magnetic resonance Imaging, EDSS

Detailed Description:

The Purpose of this research study is to develop new magnetic resonance (imaging) methods to evaluate multiple Sclerosis (MS) and thereby increase the body of knowledge about the course of this disorder. You have been invited to participate in this study to help find ways to detect changes in the brain that may be associated with the disorder that you may have. It is hoped that, in the future, these imaging techniques will enable researchers and clinicians to better detect, stage, and treat multiple sclerosis. The principal investigator for the study is Dr.Robert I. Grossman of NYU Medical Center. Other investigators are Dr.Oded Gonen Ph.D., Dr. Fredrick Lublin, Dr. Joseph Herbert and their colleagues

  1. Lesions will be assessed by measuring T2 and T1 enhanced lesion volumes and magnetization transfer ratio histogram parameters (MTRHP) in patients with relapsing-remitting and secondary-progressive disease. This data will be correlated to total brain parenchymal volume as well as identifying the effect of MS lesions on the gray and white matter, volumetric disability, including Kurtzke Expanded Disability Status Scale (EDSS) and a specific battery of neuropsychological tests.
  2. Quantitative analysis of whole brain N-acetylaspartate (WBNAA), a reproducible measure of viable neuron number, using 1H MRS and compare the results to age-matched controls over duration of 5 years.
  3. Determine the correlations between the volumetric and clinical measurements in 1 and 2.
  4. Assess whether this parameter is associated with lower WBNAA.
  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with known MS diagnosis
  2. Age 7-110 years
  3. Males or females

Exclusion Criteria:

  1. Medically unstable
  2. Artificial implants in the body
  3. Pregnant -
  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 ClinicalTrials.gov identifier: NCT01226654

Locations
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Robert I Grossman, M.D., Ph.d. NYU Langone Medical Center
  More Information

Publications:
Responsible Party: Dr. Robert Grossman, NYU Langone Medical Center
ClinicalTrials.gov Identifier: NCT01226654     History of Changes
Other Study ID Numbers: NCT00006060, 2R01NS029029-16A1
Study First Received: October 20, 2010
Last Updated: June 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Quantitative imaging of multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014