Assessment of Deep Gray Matter Anatomic Changes in RRMS Patients Treat
Assessment of Deep Gray Matter Anatomic Changes in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With Gilenya® (Fingolimod) With and Without Cognitive Impairment Over a 2 Year Period Using 3 Dimensional Volumetric MRI Studies (NeuroQuant, NeuroQuarc) and Automated Neuropsychological Assessment Matrices (ANAM)
What it found
We found no results in the registry or in papers.
This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- NeuroQuant
- Automated Neuropsychological Assessment Matrices
- EDSS
- Physical Examination
What it measured
Main measures
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
MRI lesionsThinking and memory
Other measures (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
MRI lesionsBrain volume lossCompare 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
Thinking and memory
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
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
Exclusion criteria
* 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 Control Patients Inclusion Criteria * Male and Female adult with normal brain MRI and Neurological Examination * Headaches or dizziness * Age range 18-55 years * Able to provide informed consent Exclusion Criteria * Patients with an infectious disease * Patients with any other medical or neurological condition that could affect cognition * Inability to provide informed consent * Inability to communicate in English * Pregnant or breastfeeding woman
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Dec 2013
Main results due
Sept 2016
Finished
Dec 2016