The Effects of Attention Retraining on Cognitive Performance, QoL and Perceived Cognitive Impairment in MS - a Single Blind, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 3
- 主要终点
- Subjective cognitive performance
研究概览
简要总结
The purpose of this study is to determine whether neuropsychological rehabilitation focused on attention retraining and teaching compensatory strategies has positive effects on cognitive performance, quality of life (QoL)and perceived cognitive deficits in patients with MS. The hypothesis is that the neuropsychological intervention shows positive effects on cognitive performance, QoL and perceived cognitive deficits.
详细描述
Background: Cognitive impairments are a typical manifestation of multiple sclerosis (MS). According to previous studies, neuropsychological rehabilitation may improve cognitive performance in MS. However, the quality of previous studies is low and, accordingly, the evidence on the effects of neuropsychological rehabilitation is low to modest.
Objective
To study whether neuropsychological rehabilitation improves cognitive performance, QoL and perceived cognitive deficits in patients with MS.
Methods: Altogether 100 patients with MS are randomised either to intervention or to control group in three different study sites. All the study subjects are assessed with neuropsychological tests as well as self-rating questionnaires evaluating mood, QoL, cognitive deficits, fatigue and impact of the disease at baseline, after three months (immediately after intervention) and after six months. Patients in the intervention group are offered with neuropsychological rehabilitation conducted once a week during thirteen weeks. Patients in the control group do not receive any intervention.
Results: The effects of intervention on cognitive performance, QoL and perceived cognitive impairments are evaluated using appropriate statistical procedures and comparing the differences between the intervention and the control group.
The present status: The baseline assessments have been performed and the intervention will be conducted between September and December, 2011.
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 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically definite MS
- •EDSS < 6
- •age 18-58 years
- •subjective cognitive problems and objective decline in attention
排除标准
- •other neurological disease than MS
- •psychiatric diagnosis
- •severe depression
- •secondary progressive or primary progressive course of MS
- •alcohol or drug abuse
- •relapse during the preceding month of study entry
- •neuropsychological rehabilitation during the study
- •no subjective cognitive cognitive problems and /or no decline in attention
- •overall cognitive impairment (performance in all tests of BRBNT under -1.5 SD compared to norms of healthy controls)
结局指标
主要结局
Subjective cognitive performance
时间窗: six months
The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ)
Objective cognitive performance
时间窗: six months
effects of rehabilitation on objective cognitive performance: SDMT
Goal achievement
时间窗: six months
Goal achievement: Goal Attainment Scaling (GAS)
次要结局
- Mood(six months)
- The impact of the disease(six months)
- Subjective cognitive performance(six months)
- Quality of life(six months)
- Objective cognitive performance(six months)
- Fatigue(six months)
研究者
Paivi Hamalainen
neuropsychologist, adjunct professor
Finnish MS Society