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Completed

NCT Number: NCT04448977

Examining Effects of Ocrevus on Cognitive Fatigue Using fMRI

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocrevus

Drug

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.

Primary outcomes

  1. Brain activation (BOLD signal)

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

    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).

Secondary outcomes

  1. Fatigue onset

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

    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).

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • Hackensack Meridian Health

Registry information

Official study title

A Biomarker for Cognitive Fatigue Using Functional Imaging in MS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2020
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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