Multiple Sclerosis, Relapsing-Remitting Clinical Trial
Official title:
Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis
NCT number | NCT04565431 |
Other study ID # | US-TYS-11640 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 19, 2021 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Kessler Foundation | St. Barnabas Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Fatigue onset (SDMT) | 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) | |
Secondary | 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) |
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