Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Quantitative MR Imaging and Proton Spectroscopy in MS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01226654
• Other study ID #: 9812
• Secondary ID: 2R01NS029029-16A
• Status: Terminated
• Phase: N/A
• First received: October 20, 2010
• Last updated: July 28, 2017
• Start date: August 1991
• Est. completion date: April 2016

Study information

• Verified date: July 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Magnetic Resonance Imaging
Magnetic Resonance Imaging EDSS

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years
Secondary	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	5 years