Improving Learning in MS: A Randomized Clinical Trial

描述（由申请人提供）：NCMRR咨询委员会强调了“医疗康复干预措施有效性研究"的必要性，使用新的和精确的定量测量方法，包括功能和社会限制和残疾。“目前的提案通过一项双盲、安慰剂对照、随机临床试验来研究记忆再训练对多发性硬化症（MS）的疗效，从而解决了这一建议。高级认知处理（如新的学习和记忆）的障碍是MS患者最常见的缺陷之一，并且此类缺陷已被证明对日常生活的多个方面（包括职业和社会功能）产生显著的负面影响。尽管有这些发现，很少有研究试图治疗这些认知缺陷，以改善个人MS的日常功能。通过一个小型的随机临床试验，我们发现，个人MS与记录的记忆障碍显示出显着改善他们的记忆表现后，利用图像和上下文的治疗方案，以促进学习。当前提案将复制这一发现，并进一步评价（a）治疗对日常功能的影响，（B）治疗的长期疗效和（c）加强疗程在促进长期治疗效果方面的效用。我们将随机分配患有MS的个体，记录新学习能力的损害，到记忆再训练组或安慰剂对照组。两组均将接受基线、即刻和长期随访评估，包括：（1）传统神经心理成套测试和（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经由标准评估的认知功能评估来评估这种特定记忆再训练技术在MS人群中的功效。此外，我们将能够从参与者和重要的其他人完成的问卷中得出关于这种特定记忆补救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.