Examining Effects of Tysabri on Cognitive Fatigue Using fMRI

Study Overview
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Brief Summary
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The purpose of this research study is to investigate the effectiveness of Tysabri on cognitive fatigue in persons with Relapsing-Remitting Multiple Sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.

Detailed Description
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The researchers aim is to investigate the effects of Tysabri on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with RRMS. The researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task and also on how cognitive fatigue changes as a function of duration of treatment.

Official Title
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Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: Tysabri


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Multiple Sclerosis<br>Individuals with RRMS who are going to be starting Tysabri as determined by Neurologist as part of clinical care. Intervention: Drug: Tysabri | Drug: Tysabri<br>* 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.<br>|
| Group 2: Healthy Controls<br>Healthy individuals who are age, gender and education matched to the MS group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activation (BOLD signal) | 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). | Measured by change between 2 time points (baseline and six months after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue onset | 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) | Measured by change between 2 time points (baseline and six months after intervention) | 
| Fatigue onset | 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) | Measured by change between 2 time points (baseline and six months after intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Cognitive Fatigue