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 : July 23, 2021
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis, Relapsing-Remitting||Drug: Ocrevus|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||A Biomarker for Cognitive Fatigue Using Functional Imaging in MS|
|Actual Study Start Date :||May 6, 2021|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
Multiple Sclerosis group 1
Individuals with Multiple Sclerosis who are going to be starting Ocrevus as determined by Neurologist as part of clinical care.
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 individuals who are age, gender and education matched to the other groups.
- 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).
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.||email@example.com|
|Contact: Angela Smith, M.A.||firstname.lastname@example.org|
|United States, New Jersey|
|West Orange, New Jersey, United States, 07052|
|Contact: Nancy B Moore, MA 973-324-8450 email@example.com|
|Contact: Angela Smith, M.A. 973-324-8448 firstname.lastname@example.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|