Examining Effects of Tysabri on Cognitive Fatigue Using fMRI
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|ClinicalTrials.gov Identifier: NCT04565431|
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : July 28, 2021
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis, Relapsing-Remitting||Drug: Tysabri|
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis|
|Actual Study Start Date :||March 19, 2021|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
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
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.
- Brain activation (BOLD signal) [ Time Frame: Measured by change between 2 time points (baseline and six 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 Task and Modified Fatigue Impact Scale).
- Fatigue onset [ Time Frame: Measured by change between 2 time points (baseline and six 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)
- Fatigue onset [ Time Frame: Measured by change between 2 time points (baseline and six 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 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): NCT04565431
|Contact: Nancy Moore, M.A.||firstname.lastname@example.org|
|Contact: Angela Smith, M.A.||email@example.com|
|United States, New Jersey|
|West Orange, New Jersey, United States, 07052|
|Contact: Nancy Moore, MA 973-324-8450 firstname.lastname@example.org|
|Contact: Angela Smith, MA 19733248448 email@example.com|
|Principal Investigator: John DeLuca, PhD|
|Sub-Investigator: Ekaterina Dobryakova, PhD|
|Sub-Investigator: Helen Genova, PhD|
|Sub-Investigator: Glenn Wylie, PhD|
|Principal Investigator:||John DeLuca, Ph.D.||Kessler Foundation|