Examining Effects of Ocrevus on Cognitive Fatigue Using fMRI
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ClinicalTrials.gov Identifier: NCT04448977 |
Recruitment Status :
Recruiting
First Posted : June 26, 2020
Last Update Posted : October 14, 2022
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Condition or disease | Intervention/treatment |
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Multiple Sclerosis, Relapsing-Remitting | Drug: Ocrevus |
Study Type : | Observational |
Estimated Enrollment : | 60 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | A Biomarker for Cognitive Fatigue Using Functional Imaging in MS |
Actual Study Start Date : | May 6, 2021 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | July 2023 |

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

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448977
Contact: Nancy Moore, M.A. | 973-324-8450 | nbmoore@kesslerfoundation.org | |
Contact: Angela Smith, M.A. | 973-324-8448 | asmith@kesslerfoundation.org |
United States, New Jersey | |
Kessler Foundation | Recruiting |
West Orange, New Jersey, United States, 07052 | |
Contact: Nancy B Moore, MA 973-324-8450 nbmoore@kesslerfoundation.org | |
Contact: Angela Smith, M.A. 973-324-8448 asmith@kesslerfoundation.org | |
Principal Investigator: John DeLuca, PhD | |
Sub-Investigator: Ekaterina Dobryakova, PhD | |
Sub-Investigator: Helen Genova, PhD | |
Sub-Investigator: Glenn Wylie, PhD | |
Sub-Investigator: Krupa Pandey, MD | |
Sub-Investigator: Florian Thomas, MD |
Principal Investigator: | John DeLuca, PhD | Kessler Foundation |
Responsible Party: | Kessler Foundation |
ClinicalTrials.gov Identifier: | NCT04448977 |
Other Study ID Numbers: |
R-1104-20 |
First Posted: | June 26, 2020 Key Record Dates |
Last Update Posted: | October 14, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Multiple Sclerosis cognitive fatigue |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Fatigue Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Ocrelizumab Immunologic Factors Physiological Effects of Drugs |