Improving Learning in MS: A Randomized Clinical Trial

改善多发性硬化症的学习：随机临床试验

• 批准号: 6908132
• 负责人: NANCY D. CHIARAVALLOTI
• 金额: $ 27.54万
• 依托单位: KESSLER FOUNDATION, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6908132
• 关键词: clinical research; clinical trials; cognition; cognition disorders; human subject; imagery; learning; memory; multiple sclerosis; nervous system disorder diagnosis; neuropsychological tests; patient oriented research; performance; questionnaires

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.

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、精确的损伤定量测量方法，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解决这一建议，该试验检查记忆再训练在多发性硬化症 (MS) 中的功效。高级认知处理（例如新学习和记忆）的受损是多发性硬化症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）产生显着的负面影响。尽管有这些发现，但很少有研究试图治疗这些认知缺陷，以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，我们发现患有记忆障碍的多发性硬化症患者在接受利用图像和情境促进学习的治疗方案后，其记忆表现显着改善。目前的提案将重复这一发现，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）加强疗程在促进长期治疗效果方面的效用。我们将把新学习能力有记录的多发性硬化症患者随机分配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) 传统的神经心理学电池和 (2) 整体功能评估，检查治疗对日常活动的影响。这种设计将使我们能够通过标准评估来评估认知功能，从而评估这种特定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其他重要人员完成的调查问卷中得出有关该特定记忆补救计划对日常生活的影响的结论。