Clinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo
研究概览
简要总结
Scientific background:
Growing awareness and accumulating data regarding the cognitive impairment and its progression in multiple sclerosis (MS) patients has received an important place in neurological research in the last decade.
详细描述
Scientific background:
Growing awareness and accumulating data regarding the cognitive impairment and its progression in multiple sclerosis (MS) patients has received an important place in neurological research in the last decade. Cognitive impairments occur frequently (43 to 65%) in MS. Moreover, in up to 50% of patients in whom no cognitive disturbances are found on routine neurological examination, cognitive impairments can be elicited using sensitive and disease specific neuropsychological tests. Even in patients with short disease duration of less than two years, discrete impairment of cognitive function may be found in up to 60% on neuropsychological testing without impacting activities of daily living.
We have recently reported that cognitive impairment occurred in 53.7% of patients with probable MS (evaluated within a mean of one month of the onset of new neurological symptoms). Verbal abilities and attention span were most frequently affected (43.3 and 41.8% respectively). An additional study demonstrated that MS patients within the first 5 years of disease onset presented attentional dysfunction only when the cognitive load of the attention task was high and when controlled information processing was required. This high rate of attention impairment found in MS patients early in the disease process may have a significant impact on quality of life and activities of daily living as attention is one of the most fundamental cognitive functions essential for normal daily activities and a requisite step towards conscious perception. Consequently, we suggest investigating whether treatment with Ritalin (methylphenidate) has an effect on patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Ect
- 盲法
- Double
入排标准
- 年龄范围
- 25 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of definite MS according to Poser criteria;
- •Attention impairment defined as abnormal PASAT score;
- •Written and signed informed consent;
排除标准
- •Pregnancy or lactation;
- •Steroid treatment;
- •Persistent psychostimulant treatment;
- •MS relapse;
结局指标
主要结局
Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo
次要结局
未报告次要终点
