Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Multiple Sclerosis, Cognitive Fatigue
Brief summary
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
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.
Interventions
DRUGTysabri
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.
Sponsors
St. Barnabas Medical Center
Kessler Foundation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain activation (BOLD signal) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue onset (SDMT) | 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 | 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) |
Countries
United States
Contacts
Primary ContactNancy Moore, M.A.
Backup ContactAngela Smith, M.A.
Outcome results
None listed