Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by New York University School of Medicine.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
New York University School of Medicine
Collaborator:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01226654
First received: October 20, 2010
Last updated: October 21, 2010
Last verified: October 2010
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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: | Allocation: Non-Randomized 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 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Other: Magnetic Resonance Imaging
Magnetic resonance Imaging, EDSS
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
- 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.
- 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.
- Determine the correlations between the volumetric and clinical measurements in 1 and 2.
- 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:
- Patients with known MS diagnosis
- Age 7-110 years
- Males or females
Exclusion Criteria:
- Medically unstable
- Artificial implants in the body
- Pregnant -
Contacts and Locations
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: | October 21, 2010 |
| 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 June 18, 2013