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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2024 |
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Main ID: |
NCT04565431 |
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Date of registration:
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25/08/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Examining Effects of Tysabri on Cognitive Fatigue Using fMRI
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Scientific title:
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Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis |
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Date of first enrolment:
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March 19, 2021 |
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Target sample size:
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25 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04565431 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Nancy Moore, MA |
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Address:
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Telephone:
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973-324-8450 |
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Email:
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nbmoore@kesslerfoundation.org |
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Affiliation:
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Name:
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Nancy Moore, M.A. |
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Address:
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Telephone:
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19733248450 |
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Email:
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nbmoore@kesslerfoundation.org |
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Affiliation:
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Name:
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John DeLuca, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kessler Foundation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age between 18-64
- 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:
- 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
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis, Relapsing-Remitting
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Intervention(s)
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Drug: Tysabri
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Primary Outcome(s)
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Brain activation (BOLD signal)
[Time Frame: Measured by change between 2 time points (baseline and six months after intervention)]
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Secondary Outcome(s)
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Fatigue onset (SDMT)
[Time Frame: Measured by change between 2 time points (baseline and six months after intervention)]
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Fatigue onset
[Time Frame: Measured by change between 2 time points (baseline and six months after intervention)]
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Secondary ID(s)
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US-TYS-11640
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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