Examining Effects of Ocrevus on Cognitive Fatigue Using fMRI

February 13, 2024 updated by: Kessler Foundation

A Biomarker for Cognitive Fatigue Using Functional Imaging in MS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Recruiting
        • Kessler Foundation
        • Contact:
        • Contact:
        • Principal Investigator:
          • John DeLuca, PhD
        • Sub-Investigator:
          • Helen Genova, PhD
        • Sub-Investigator:
          • Glenn Wylie, PhD
        • Sub-Investigator:
          • Krupa Pandey, MD
        • Sub-Investigator:
          • Florian Thomas, MD
        • Sub-Investigator:
          • Ekaterina Dobryakova, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Individuals who have Relapsing remitting Multiple Sclerosis and Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multiple Sclerosis group 1
Individuals with Multiple Sclerosis who are going to be starting Ocrevus as determined by Neurologist as part of clinical care.
Drug: Ocrevus
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.
Multiple Sclerosis group 2
Individuals with Multiple Sclerosis who are going to be starting Copaxone as determined by Neurologist as part of clinical care.
Healthy Controls
Healthy individuals who are age, gender and education matched to the other groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Measured for change at 3 time points (before, six months and 12 months after intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Measured for change at 3 time points for change (before, six months and 12 months after intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

Hackensack Meridian Health

Investigators

  • Principal Investigator: John DeLuca, PhD, Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-1104-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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