UMR 7039, Université de Lorraine, CNRS, Vandœuvre-lès-Nancy, France.
Department of Neurology, Nancy University Hospital, Nancy, France.
Clin Rehabil. 2020 Jun;34(6):754-763. doi: 10.1177/0269215520920333.
The aim of this study is to determine the effectiveness of an extended cognitive rehabilitation program in group's sessions in multiple sclerosis.
Double-blind multicenter randomized trial.
People with multiple sclerosis of 18 to 60 years, Expanded Disability Status Scale ⩽6.0, mild to moderate cognitive impairment.
They were randomized into cognitive rehabilitation program (ProCog-SEP) or in a placebo program. ProCog-SEP comprises 13 group's sessions over 6 months and includes psychoeducational advices and cognitive exercises. Placebo program included non-cognitive exercises. No strategy and no cognitive advice were provided.
The primary endpoint was the percentage of verbal memory learning measured by the Selective Reminding Test. A comprehensive neuropsychological assessment is carried out before and after interventions by a neuropsychologist blinded to intervention. Effectiveness of the ProCog-SEP versus Placebo has been verified using linear regression models.
In total, 128 participants were randomized and 110 were included in the study after planning session in groups; 101 completed this trial (77.2% females); mean age: 46.1 years (±9.6); disease duration: 11.8 years (±7.5). ProCog-SEP was more effective in increasing in learning index (9.21 (95% confidence interval (CI): 1.43, 16.99); = 0.02) and in working memory on manipulation (0.63 (95% CI: 0.17, 1.09); = 0.01), and updating capacities (-1.1 (95% CI: -2.13, -0.06); = 0.04). No difference was observed for other neuropsychological outcomes. Regarding quality of life outcomes, no change was observed between the two groups.
These findings suggest that ProCog-SEP could improve verbal learning abilities and working memory in people with multiple sclerosis. These improvements were observed with 13 group sessions over 6 months.
本研究旨在确定在多发性硬化症患者中进行多次小组认知康复治疗的效果。
双盲、多中心、随机试验。
年龄在 18 至 60 岁之间、扩展残疾状况量表评分≤6.0、有轻度至中度认知障碍的多发性硬化症患者。
他们被随机分为认知康复治疗组（ProCog-SEP）或安慰剂组。ProCog-SEP 包括 13 次小组课程，持续 6 个月，其中包括心理教育建议和认知练习。安慰剂组包括非认知练习。不提供任何策略和认知建议。
主要终点是通过选择性回忆测试测量的言语记忆学习的百分比。在小组计划会议之后，由一位对干预措施不知情的神经心理学家对所有参与者进行全面的神经心理学评估。使用线性回归模型验证 ProCog-SEP 与安慰剂的有效性。
共有 128 名参与者被随机分配，110 名参与者在小组计划会议后被纳入研究；101 名参与者完成了这项试验（77.2%为女性）；平均年龄为 46.1 岁（±9.6）；疾病持续时间为 11.8 年（±7.5）。ProCog-SEP 更能有效地提高学习指数（9.21（95%置信区间：1.43，16.99）； = 0.02）和工作记忆操作（0.63（95%置信区间：0.17，1.09）； = 0.01），以及更新能力（-1.1（95%置信区间：-2.13，-0.06）； = 0.04）。在其他神经心理学结果方面没有观察到差异。关于生活质量结果，两组之间没有变化。
这些发现表明，ProCog-SEP 可以改善多发性硬化症患者的言语学习能力和工作记忆。这些改善是在 6 个月内进行 13 次小组课程后观察到的。
