Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant
研究概览
简要总结
Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS) but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
详细描述
Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in MS but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Relapsing MS since at least 6 months and less than 10 years
- •Neurological state stable since at least 1 month
- •Moderate Handicap (EDSS ≤ 5,5)
排除标准
- •Secondary Progressive MS
- •Patient having an attack
- •Patient having experienced en MS relapse or recovered systemic corticosteroid in the previous 1 month
- •Depressive patient
研究组 & 干预措施
sclerosis
干预措施: Neuropsychological assessment (Other)
结局指标
主要结局
Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant
时间窗: on a 36 months period
次要结局
- Analysis of variance for repeated measurement(15 to 30 days before the beginning of treatment, after 36 months)
- Reverse span(15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months)
- • Tiredness (EMIF SEP scale): Analysis of variance for repeated measurement(15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months)
- Disability (EDSS) : Analysis of variance for repeated measurement(15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months)
- Selective Reminding Test (SRT)(15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months)
- Delayed recall of SRT(15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months)
- Visuo-spatial span(15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months)
- Digit span(15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months)
- • Psychological disorder (Beck depression inventory, COVI scale, Depressive scale) : Analysis of variance for repeated measurement(15 to 30 days before the beginning of treatment, 1st day of the treatment, after 6,12,18 and 36 months)
- Stroop test(15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months)
- • Physical function (9HPT, 8 meter walk) : Analysis of variance for repeated measurement(15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months)