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: 7052886
• 负责人: NANCY D. CHIARAVALLOTI
• 金额: $ 26.89万
• 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/7052886
• 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“研究医疗康复干预的有效性……使用新的和精确的损伤量化测量，包括功能和社会限制和残疾。”目前的建议通过一项双盲、安慰剂对照的随机临床试验来解决这一建议，该临床试验检验了记忆再训练对多发性硬化症(MS)的疗效。高水平认知加工障碍，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显著的负面影响，包括职业和社会功能。尽管有这些发现，但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，有记录的记忆障碍的多发性硬化症患者在采用利用意象和上下文促进学习的治疗方案后，其记忆表现显著改善。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。我们将随机将有新学习能力障碍的多发性硬化症患者分配到记忆再训练组或安慰剂对照组。两组都将接受基线、即时和长期的后续评估，包括：(1)传统的神经心理单元和(2)全球功能评估，检查治疗对日常活动的影响。这一设计将使我们能够通过标准评估评估认知功能，评估这种特殊记忆再训练技术在多发性硬化症人群中的有效性。此外，我们将能够从参与者和另一位重要参与者完成的问卷中得出关于这一特定记忆补救计划对日常生活的影响的结论。