Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by New York University School of Medicine
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01226654
First received: October 20, 2010
Last updated: April 13, 2016
Last verified: April 2016
  Purpose
The primary purpose of this study is to detect changes in the brain that may be associated with multiple sclerosis. Results will be compared to age matched controls. Investigators will assess lesions 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. 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.

Condition Intervention
Multiple Sclerosis
Device: Magnetic Resonance Imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MS Patients
All subjects enrolled in this study will undergo MRI studies. A computerized neuropsychological battery of tests will be administered.
Device: Magnetic Resonance Imaging
Magnetic Resonance Imaging EDSS
Healthy Patients
Patients enrolled in this study will undergo MRI studies. A computerized neuropsychological battery of tests will be administered.
Device: Magnetic Resonance Imaging
Magnetic Resonance Imaging EDSS

  Eligibility

Ages Eligible for Study:   7 Years to 110 Years   (Child, Adult, Senior)
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

Normal Controls

  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

Contacts
Contact: Jacqueline Smith 212-263-3335 Jacqueline.Smith4@nyumc.org
Contact: Martin E Donach, M.D. 212-263-3339 Martin.Donach@nyumc.org

Locations
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Jacqueline Smith    212-263-3335    Jacqueline.Smith4@nyumc.org   
Contact: Martin E Donach, M.D.    212-263-3339    Martin.Donach@nyumc.org   
Sponsors and Collaborators
New York University School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Yulin Ge, M.D. NYU Langone Medical Center
  More Information

Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01226654     History of Changes
Other Study ID Numbers: 9812  2R01NS029029-16A1 
Study First Received: October 20, 2010
Last Updated: April 13, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
Quantitative Imaging of Multiple Sclerosis

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

ClinicalTrials.gov processed this record on August 25, 2016