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Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01226654
Recruitment Status : Terminated
First Posted : October 22, 2010
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis Device: Magnetic Resonance Imaging Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative MR Imaging and Proton Spectroscopy in MS
Study Start Date : August 1991
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Assess the MS lesions using Magnetization transfer ratio histogram parameters and compare it to total brain parenchymal volume [ Time Frame: 5 years ]
    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 :
  1. Quantitative analysis of whole brain N-acetylaspartate (WBNAA) [ Time Frame: 5 years ]
    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



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Ages Eligible for Study:   7 Years to 110 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Yulin Ge, M.D. NYU Langone Medical Center

Publications of Results:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01226654     History of Changes
Other Study ID Numbers: 9812
2R01NS029029-16A1 ( U.S. NIH Grant/Contract )
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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