Examining Effects of Ocrevus on Cognitive Fatigue Using fMRI
NCT ID: NCT04448977
Last Updated: 2024-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2021-05-06
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
No interventions assigned to this group
Healthy Controls
Healthy individuals who are age, gender and education matched to the other groups.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
Yes
Sponsors
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Hackensack Meridian Health
OTHER
Kessler Foundation
OTHER
Responsible Party
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Principal Investigators
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John DeLuca, PhD
Role: PRINCIPAL_INVESTIGATOR
Kessler Foundation
Locations
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Kessler Foundation
West Orange, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R-1104-20
Identifier Type: -
Identifier Source: org_study_id
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