NCT01226654

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Aug 1991

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1991

Completed
19.2 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

24.7 years

First QC Date

October 20, 2010

Last Update Submit

July 28, 2017

Conditions

Multiple Sclerosis

Keywords

Quantitative Imaging of Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quantitative analysis of whole brain N-acetylaspartate (WBNAA)

    5 years

Study Arms (2)

MS Patients

OTHER

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

Device: Magnetic Resonance Imaging

Healthy Patients

OTHER

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

Device: Magnetic Resonance Imaging

Interventions

Magnetic Resonance ImagingDEVICE

Magnetic Resonance Imaging EDSS

Healthy PatientsMS Patients

Eligibility Criteria

Age7 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with known MS diagnosis
  • Age 7-110 years
  • Males or females

You may not qualify if:

  • Medically unstable
  • Artificial implants in the body
  • Pregnant
  • Normal Controls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related 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: 10.1002/jmri.21758.

    PMID: 19388109RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Yulin Ge, M.D.

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 22, 2010

Study Start

August 1, 1991

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

US(1)