Clinical trial NCT05684016: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing Remitting Multiple Sclerosis
RRMS
Gilenya
Fingolimod
MRI
NeuroQuant
NeuroQuarc
Automated Neuropsychological Assessment Matrices
ANAM
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 2 Years
Secondary outcomes:
measure: 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.
timeFrame: 2 Years
measure: Compare Neuropsychological Evaluations using ANAM to address cognitive changes in patients treated with Gilenya over time as compared to healthy aged matched control patients.
timeFrame: 2 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washignton University
state: District of Columbia
Study officials:
affiliation: The George Washington University
name: Ted Rothstein, MD
role: PRINCIPAL_INVESTIGATOR
References: