Examining Effects of Ocrevus on Cognitive Fatigue Using fMRI

Kessler Foundation24 enrolled

Overview

The purpose of this research study is to investigate the effectiveness of MS Disease modifying medications on cognitive fatigue in persons with relapsing remitting multiple sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.

The researchers aim is to investigate the effects of disease modifying treatments on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with Multiple Sclerosis (MS). The researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task, and also on how cognitive fatigue changes as a function of duration of treatment.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

OcrevusDRUG

Participants with MS will be divided into two treatment groups: those who will begin to take Ocrevus (the "early Ocrevus" group (EO), and those who plan to be begin treatment with Glatimer acetate SC (Copaxone) (EC). Both groups will be matched to the EO group for age, gender and education. The HC group will be free of neurological disease or injury and will be matched to the EO group for age, gender, and education.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18-64. * Relapsing remitting multiple sclerosis * Been newly prescribed a new disease modifying medication for MS (either Ocrevus or Copaxone) * or healthy volunteer who can speak English fluently. Exclusion Criteria: * History of head injury, stroke, seizures, or any other significant neurological event other than MS * Flare up of MS symptoms within the past month. * History of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder. * Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids \[cochlear implants\]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments. * left handed. * Not able to have an MRI

Locations (1)

Kessler Foundation

West Orange, New Jersey, United States

Outcomes

Primary Outcomes

Brain activation (BOLD signal)

A change in brain activation as measured with functional magnetic resonance imaging through blood oxygen level dependent signal will be measured in association with cognitive fatigue (as measured by the Visual Analogue scale during performance of the modified Symbol Digit Modality and Modified Fatigue Impact Scale).

Time frame: Measured for change at 3 time points (before, six months and 12 months after intervention)

Secondary Outcomes

Fatigue onset

A change in the speed with which modified Symbol Digit Modality task (a cognitively demanding task) induces fatigue in MS (as measured by the Visual Analogue scale and Modified Fatigue Impact Scale).

Time frame: Measured for change at 3 time points for change (before, six months and 12 months after intervention)

Data from ClinicalTrials.gov

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