Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis

NCT ID: NCT01226654

Last Updated: 2017-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-08-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MS Patients

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

Group Type OTHER

Magnetic Resonance Imaging

Intervention Type DEVICE

Magnetic Resonance Imaging EDSS

Healthy Patients

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

Group Type OTHER

Magnetic Resonance Imaging

Intervention Type DEVICE

Magnetic Resonance Imaging EDSS

Interventions

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Magnetic Resonance Imaging

Magnetic Resonance Imaging EDSS

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yulin Ge, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

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NYU Langone Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19388109 (View on PubMed)

Other Identifiers

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2R01NS029029-16A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9812

Identifier Type: -

Identifier Source: org_study_id

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