Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis

Not Applicable

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Device: Magnetic Resonance Imaging

• Registration Number: NCT01226654
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1991-08
• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Patients	Magnetic Resonance Imaging	Patients enrolled in this study will undergo MRI studies. A computerized neuropsychological battery of tests will be administered.
MS Patients	Magnetic Resonance Imaging	All subjects enrolled in this study will undergo MRI studies. A computerized neuropsychological battery of tests will be administered.

Primary Outcome Measures

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

Name	Time	Method
Quantitative analysis of whole brain N-acetylaspartate (WBNAA)	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

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States