Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Relapsing Remitting Multiple Sclerosis, RRMS, Gilenya, Fingolimod, MRI, NeuroQuant, NeuroQuarc, Automated Neuropsychological Assessment Matrices, ANAM
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.
Detailed description
Impairment in thinking or memory is frequently present in multiple sclerosis but there are difficulties finding changes on the Brain MRI that correlate with impairment in thinking and memory. This occurs because standard MRI is good for detecting some but not all abnormalities in the brain. Those lesions that we do see in the brain on standard MRI do not correlate with memory impairment or the source of disability in most RRMS patients. This occurs because RRMS symptoms mainly result from parts of the brain which have been hard to evaluate with MRI until now. To gain more insight into the source of memory impairment, we plan to explore differences in brain volume that may be present in RRMS patients without thinking or memory problems compared with those who are impaired. A secondary objective will be to compare RRMS patients in general with healthy controls. A new MRI technique called NeuroQuant which reliably defines the volume of those parts of the brain that are important for memory and thinking will be used. Neuropsychological testing will also be offered, at no cost, to those patients being treated with Gilenya® in order to help define the presence and extent of their memory impairment. Automated Neuropsychological Assessment Matrices (ANAM)looks at all functional brain systems and will be administered by a psychometrist over a period of 90 minutes.
Interventions
OTHERPhysical Examination
Physical Examination
OTHERNeuroQuant
Reliably defines the volume of those parts of the brain that are important for memory and thinking.
OTHERAutomated Neuropsychological Assessment Matrices
This is like an IQ test.
OTHEREDSS
Extended Disability Status Score
Sponsors
George Washington University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion and
Exclusion criteria
RRMS Patients Inclusion Criteria * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 Years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | a. Use serial MRI 3 dimensional volumetric analysis (NeuroQuant) at baseline, 1 week (in 20 patients) and 1 and 2 years to assess reproducibility of NeuroQuant, and determine the degree of preservation of gray matter structures in RRMS patients treated with Gilenya® over a period of 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 | Baseline neuropsychological evaluations on patients treated with Gilenya based on results of an Automated Neuropsychological Assessment Matrices (ANAM). Healthy controls will also undergo this neuropsychological assessment. Both groups will be repeatedly tested over time for 2 years. |
Countries
United States
Outcome results
None listed