Multidimensional Assessment of Fatigue in Multiple Sclerosis- Observational Study - Ticino
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
Fatigue is a common symptom in patients with multiple sclerosis, however, its nature is not completely understood. Fatigue overlaps often with other symptoms such as somnolence, depression and cognitive disorders, from which it is not always readily distinguished. The evaluation of fatigue and the three most frequently associated symptoms using a multidimensional approach might allow to understand, which methodology is the best indicated to estimate the prevalence of fatigue with greatest accuracy, leading to a better differentiation of the symptoms in the diagnostic setting.
详细描述
Objectives: 1- to provide a detailed characterization of fatigue in a cohort of selected MS patients, including a definition of the boundaries and the overlaps between fatigue, somnolence, mood disorders and attention dysfunction; 2- to see how the prevalence and the overlaps between fatigue, somnolence, depression and attention dysfunction are influenced by the method of assessment. 3-To better characterize the sleep structure in MS patients with fatigue under both the macro- and microstructural point of view.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Definite diagnosis of MS (14,15) or CIS (16);according to the most recent standard criteria
- •Expanded Disability Status Scale (EDSS) score < 7.0 (17);
- •Last magnetic resonance imaging (MRI) within the previous 12 months;
- •Male or female;
- •>18 years old;
- •Willing to perform the study procedures;
- •Signed Informed consent.
排除标准
- •Mini Mental Status Examination (MMSE) score < 24;
- •Relapse within the last 3 months;
- •Radiologically isolated syndrome (RIS);
- •History of drug and/or alcohol abuse;
- •Any serious general medical condition like decompensated cardiopulmonary disease, cancer or decompensated renal failure, as well as any neurological condition (other than MS) that can interfere with the correct execution of the study design.
结局指标
主要结局
Fatigue Severity Scale
时间窗: 1 Day
a self-administered 9-items scale. The patient gives a score from 1 to 7 to each item. The resulting score is given as the mean value. Subjects with a score higher that 4 are considered fatigued. This scale assesses the impact of fatigue on multiple outcomes, with a physical focus. FSS has been validated for MS, it has an acceptable internal consistency, it is a reliable, completely safe and brief scale, which in addition has been shown to follow clinical changes in fatigue perception over time. Furthermore, FSS scores correlate with other commonly used fatigue scales, like the Modified Fatigue Impact Scale
次要结局
- Modified Fatigue Impact Scale(1 Day)
- Fatigue Scale for Motor and Cognitive functions(1 Day)
- Visual analogue scale for fatigue(1 Day)
- Maintenance of wakefulness test(1 Day)
- Epworth Sleepiness Scale(1 Day)
- Visual analogue scale for somnolence(1 Day)
- Beck depression inventory II(1 Day)
- Paced Auditory Serial Addition Test(1 Day)
- Mongomery Asberg Depression Rating Scale(1 Day)
- Symbol Digit Modalities Test(1 Day)
- Stroop Test(1 Day)
研究者
Claudio Gobbi
Dr med., Vice head physician
Ospedale Civico, Lugano