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Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Quantitative Imaging of Multiple Sclerosis

Eligibility Criteria

7 Years - 110 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NYU Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

MS Patients

Healthy Patients

Arm Description

All subjects enrolled in this study will undergo MRI studies. A computerized neuropsychological battery of tests will be administered.

Patients enrolled in this study will undergo MRI studies. A computerized neuropsychological battery of tests will be administered.

Outcomes

Primary Outcome Measures

Assess the MS lesions using Magnetization transfer ratio histogram parameters and compare it to total brain parenchymal volume
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)
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

Full Information

First Posted
October 20, 2010
Last Updated
July 28, 2017
Sponsor
NYU Langone Health
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT01226654
Brief Title
Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis
Official Title
Quantitative MR Imaging and Proton Spectroscopy in MS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Study Start Date
August 1991 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Quantitative Imaging of Multiple Sclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MS Patients
Arm Type
Other
Arm Description
All subjects enrolled in this study will undergo MRI studies. A computerized neuropsychological battery of tests will be administered.
Arm Title
Healthy Patients
Arm Type
Other
Arm Description
Patients enrolled in this study will undergo MRI studies. A computerized neuropsychological battery of tests will be administered.
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
Magnetic Resonance Imaging EDSS
Primary Outcome Measure Information:
Title
Assess the MS lesions using Magnetization transfer ratio histogram parameters and compare it to total brain parenchymal volume
Description
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Quantitative analysis of whole brain N-acetylaspartate (WBNAA)
Description
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
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with known MS diagnosis Age 7-110 years Males or females Exclusion Criteria: Medically unstable Artificial implants in the body Pregnant Normal Controls
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yulin Ge, M.D.
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19388109
Citation
Ge Y, Zohrabian VM, Osa EO, Xu J, Jaggi H, Herbert J, Haacke EM, Grossman RI. Diminished visibility of cerebral venous vasculature in multiple sclerosis by susceptibility-weighted imaging at 3.0 Tesla. J Magn Reson Imaging. 2009 May;29(5):1190-4. doi: 10.1002/jmri.21758.
Results Reference
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Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis

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