Improving Learning in MS: A Randomized Clinical Trial

描述（由申请人提供）：NCMRR咨询委员会强调需要“研究医疗康复干预措施的有效性……使用新的和精确的定量测量损伤，包括功能和社会限制和残疾。”目前的建议是通过一项双盲、安慰剂对照的随机临床试验来验证记忆再训练对多发性硬化症（MS）的疗效。高级认知加工的损伤，如新的学习和记忆，是多发性硬化症患者最常见的缺陷之一，这种缺陷已被证明对日常生活的多个方面产生重大的负面影响，包括职业和社会功能。尽管有这些发现，很少有研究试图通过治疗这些认知缺陷来改善多发性硬化症患者的日常功能。通过一项小型随机临床试验，我们发现有记忆障碍的多发性硬化症患者在使用图像和背景促进学习的治疗方案后，他们的记忆表现有显著改善。目前的建议将重复这一发现，并进一步评估(a)治疗对日常功能的影响，(b)治疗的长期疗效，以及(c)加强治疗在促进长期治疗效果方面的效用。我们将随机分配有新学习能力受损记录的多发性硬化症患者到记忆再训练组或安慰剂对照组。两组都将接受基线、即时和长期随访评估，包括：(1)传统的神经心理学测试；(2)检查治疗对日常活动影响的整体功能评估。该设计将允许我们通过标准评估认知功能来评估这种特殊的记忆再训练技术在多发性硬化症人群中的功效。此外，我们将能够从参与者和另一个重要的人完成的问卷中得出关于这种特殊的记忆修复计划对日常生活的影响的结论。

DESCRIPTION (provided by applicant): The Advisory Board of the NCMRR has underscored the need for "studies of the effectiveness of medical rehabilitation interventions.., using new and precise quantitative measurements of impairment, including functional and societal limitations and disability." The current proposal addresses this recommendation through a double-blind, placebo-control randomized clinical trial examining the efficacy of memory retraining in Multiple Sclerosis (MS). Impairment in higher level cognitive processing, such as new learning and memory, is one of the most common deficits in individuals with MS and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to treat these cognitive deficits in order to improve the everyday functioning of individuals with MS. Through a small randomized clinical trial, we found that individuals with MS with documented memory impairment show a significant improvement in their memory performance following a treatment protocol utilizing imagery and context to facilitate learning. The current proposal will replicate this finding and further evaluate (a) the impact of the treatment on everyday functioning, (b) the long term efficacy of the treatment and (c) the utility of booster sessions in facilitating long-term treatment effects. We will randomly assign individuals with MS, with documented impairment in new learning abilities, to a memory retraining group or a placebo control group. Both groups will undergo baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. This design will allow us to evaluate the efficacy of this particular memory retraining technique in an MS population through the assessment of cognitive function via a standard evaluation. In addition, we will be able to draw conclusions regarding the impact of this particular memory remediation program on everyday life from questionnaires completed by the participant and a significant other.