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

George Washington University (GW)

Status

Completed

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Other: NeuroQuant

Other: EDSS

Other: Physical Examination

Other: Automated Neuropsychological Assessment Matrices

Study type

Interventional

Funder types

Other

Identifiers

NCT05684016

ADEG-MS-3DV

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

Control

Active Comparator group

Description:

A 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.

Treatment:

Other: Automated Neuropsychological Assessment Matrices

Other: NeuroQuant

MS Subject on Gilenya

Active Comparator group

Description:

All 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

Treatment:

Other: Automated Neuropsychological Assessment Matrices

Other: Physical Examination

Other: EDSS

Other: NeuroQuant

MS Subject not on Gilenya

Active Comparator group

Description:

All the RRMS patients will have their Brain MRI with the addition of NeuroQuant.

Treatment:

Other: Physical Examination

Other: EDSS