Examining Effects of Tysabri on Cognitive Fatigue Using fMRI
NCT ID: NCT04565431
Last Updated: 2024-02-15
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
25 participants
OBSERVATIONAL
2021-03-19
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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Group 1: Multiple Sclerosis
Individuals with RRMS who are going to be starting Tysabri as determined by Neurologist as part of clinical care.
Intervention: Drug: Tysabri
Tysabri
Participants with RRMS who are planning to begin treatment with Tysabri will be compared to a group of healthy individuals who are matched for age, gender, and education.
Group 2: Healthy Controls
Healthy individuals who are age, gender and education matched to the MS group.
No interventions assigned to this group
Interventions
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Tysabri
Participants with RRMS who are planning to begin treatment with Tysabri will be compared to a group of healthy individuals who are matched for age, gender, and education.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Relapsing-Remitting Multiple Sclerosis or a healthy volunteer
* If diagnosed with MS: has been newly prescribed Tysabri, but has not yet started taking the medication
* Can read and 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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St. Barnabas Medical Center
OTHER
Kessler Foundation
OTHER
Responsible Party
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Principal Investigators
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John DeLuca, Ph.D.
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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US-TYS-11640
Identifier Type: -
Identifier Source: org_study_id
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