Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Brain activation (BOLD signal)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 2: Healthy Controls
Healthy individuals who are age, gender and education matched to the MS group.
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
干预措施: Tysabri (Drug)
结局指标
主要结局
Brain activation (BOLD signal)
时间窗: 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).
次要结局
- Fatigue onset (SDMT)(Measured by change between 2 time points (baseline and six months after intervention))
- Fatigue onset(Measured by change between 2 time points (baseline and six months after intervention))
研究者
John DeLuca
Sr. Vice President for Research
Kessler Foundation