Assessment of Deep Gray Matter Anatomic Changes in RRMS Patients Treated With Gilenya® With and Without Cognitive Impairment Over a 2 Year Period Using NeuroQuant, NeuroQuarc and ANAM
NeuroQuant
1 other identifier
interventional
75
1 country
1
Brief Summary
The purpose of the research study is to investigate whether the extent and severity of lesions in the brain as measured by special MRI techniques can distinguish between Multiple Sclerosis (MS) patients with or without memory impairment and also between MS patients and age matched healthy controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
January 13, 2023
CompletedJanuary 13, 2023
January 1, 2023
2.8 years
January 8, 2015
January 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in size of brain region by cm3 over a 2 year period in RRMS patients with and without cognitive impairment compared to healthy age matched controls
a. Utilizing MRI 3 dimensional volumetric analysis (NeuroQuant) to detect gray matter changes in RRMS with or without cognitive impairment and compare results with normal demographically similar age matched controls.
2 Years
Secondary Outcomes (2)
Determine in patients with RRMS treated with Gilenya®, the changes on various gray matter volume as assessed by serial NeuroQuant/NeuroQuarc 3 dimensional volumetric analysis over a 2 year period.
2 Years
Compare Neuropsychological Evaluations using ANAM to address cognitive changes in patients treated with Gilenya over time as compared to healthy aged matched control patients.
2 years
Study Arms (3)
Control
ACTIVE COMPARATORA control population (Non RRMS) will include a minimum of 20 age and gender matched healthy patients from the George Washington University (GWU) neurology outpatient clinic (being compared with those RRMS patients being treated with Gilenya® ) for whom Brain MRI's are being ordered as a result of their having headaches, dizziness, or other conditions where there is no physical evidence for neurologic impairment. All control patients will only be recruited by the full time Neurology Faculty at the GWU Medical Faculty Associates (MFA). Control patients will be asked to consent to have NeuroQuant added to their routine Brain MRI which will add 7 minutes to their time in the MRI scanner to obtain additional image data.
MS Subject on Gilenya
ACTIVE COMPARATORAll the RRMS patients will have their Brain MRI with the addition of NeuroQuant. The 30 patients that are taking Gilenya® will have serial NeuroQuant/MRI and Neuropsychological testing (which is like an IQ test) using Automated Neuropsychological Assessment Matrices (ANAM) whether they are or are not experiencing cognitive issues. In addition, each study patient will undergo Extended Disability Status Score (EDSS) evaluation by a physician or a physician assistant at baseline and at 1 and 2 years. A group of 20 RRMS patients will undergo a second Brain MRI (not standard of care) with NeuroQuant evaluation 7 to 14 days after the initial study in order to confirm the reproducibility of this imaging technique. The cost for this repeat MRI will not be charged to you but will be borne by the sponsors of this study
MS Subject not on Gilenya
ACTIVE COMPARATORAll the RRMS patients will have their Brain MRI with the addition of NeuroQuant.
Interventions
Reliably defines the volume of those parts of the brain that are important for memory and thinking.
This is like an IQ test.
Eligibility Criteria
You may not qualify if:
- RRMS Patients
- Male and Female adult definite RRMS patients with or without cognitive complaint
- Age range 18-55 years old
- Patients treated with Gilenya® (fingolimod) and other immunomodulating MS therapies
- Able to provide informed consent
- Pregnant or breastfeeding women
- Patients with an infectious disease
- Patients with any other medical or neurological condition that could affect cognition
- Inability to communicate in English
- Patients with clinically or radiologically isolated syndrome (CIS, RIS)
- Primary or Secondary Progressive forms of MS
- Current or past medical, neurological or psychiatric disorders (other than MS)
- Previous illicit substance dependence or substance abuse
- Pulse or steroid therapy within 8 weeks or preceding evaluation
- Current major depressive episode
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The George Washignton University
Washington D.C., District of Columbia, 20037, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ted Rothstein, MD
The George Washington University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Neurology
Study Record Dates
First Submitted
January 8, 2015
First Posted
January 13, 2023
Study Start
December 1, 2013
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
January 13, 2023
Record last verified: 2023-01