Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS

对改善多发性硬化症新学习和记忆的理论驱动手动方法的评估

• 批准号: 10380805
• 负责人: NANCY D. CHIARAVALLOTI
• 金额: $ 36.3万
• 依托单位: KESSLER FOUNDATION, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-10 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10380805
• 关键词: Address; Aftercare; Brain; Caregiver Burden; Cognition; Cognitive Science; Data; Development; Disabled Persons; Double-Blind Method; Educational process of instructing; Evaluation; Generations; Impairment; Individual; Intervention; Learning; Life; Literature; Manuals; Measures; Medical center; Memory; Memory impairment; Methodology; Multiple Sclerosis; National Institute of Child Health and Human Development; Neuropsychology; Occupational; Outcome; Outcome Measure; Participant; Patients; Performance; Population; Population Intervention; Protocols documentation; Publications; Quality of life; Questionnaires; Recommendation; Rehabilitation therapy; Research; Research Design; Retrieval; Shivering; Social Functioning; Societies; Standardization; Structure; Techniques; Time; Training; Treatment Protocols; United States National Institutes of Health; Work; cognitive performance; cognitive rehabilitation; daily functioning; design; disability; efficacious treatment; efficacy evaluation; efficacy testing; evidence base; follow-up; improved; innovation; interest; multiple sclerosis patient; neural correlate; neuroimaging; neuromechanism; novel; optimism; randomized placebo-controlled clinical trial; randomized, clinical trials; reduce symptoms; rehabilitation research; remediation; self testing; social; standardize measure; theories; treatment effect

Project Summary Impairments in new learning and memory are common in Multiple Sclerosis (MS) and negatively impact several aspects of everyday life, including occupational and social functioning. Despite the demand for learning and memory treatments few cognitive rehabilitation (CR) protocols to date are supported by Class I research evidence, thereby limiting the degree to which potentially efficacious treatments may be applied to MS. To address this critical need, the presently proposed randomized clinical trial (RCT) examines the efficacy of an 8-session CR protocol encompassing training in the application of three strategies (self-generation, spaced learning and self-testing) with the greatest empirical evidence to treat impaired learning and memory in persons with MS, Strategy-based Training to Enhance Memory (STEM). The currently proposed double-blind placebo-controlled randomized clinical trial (RCT) addresses a central objective highlighted in the NCMRR 2016 Research Plan by seeking to reduce “symptoms and secondary conditions associated with disability through the development, adaptation or evaluation on interventions” (p. 1531). We will conduct a double-blind, placebo-controlled RCT, administering STEM to 120 participants with MS who evidence NLM deficits. Outcome will be assessed via 3 mechanisms, an Assessment of Global Functioning (AGF), which examines everyday functioning and quality of life, a Neuropsychological Evaluation (NPE) to examine objective cognitive performance, and neuroimaging to elucidate neural mechanisms of STEM and its mechanisms. The examination of daily life activities as an a priori endpoint in this RCT is a highly innovative aspect of the currently proposed work, highlighted as a significant gap in the rehabilitation literature by the NCMRR1. We will additionally evaluate the longer-term efficacy of STEM on everyday functioning and NPE through a 6-month follow-up evaluation and evaluate the impact of booster sessions in maintaining the treatment effect over time. Importantly, the rigorous research design employed in the current study is highly responsive to the objectives set forth by the NCMRR in their most recent research plan, to “increase the quality of evidence for rehabilitation interventions …through increased focus on the design…and outcomes of these interventions” (p. 152). Such “evidence based approaches are essential for rehabilitation research” (NCMRR, 20162) Supported by strong preliminary data, this novel and innovative intervention has the potential to significantly remediate NLM deficits in persons with MS, ultimately leading to improved social and occupational functioning (i.e., participation) and overall QOL. Results of the current study will provide Class I evidence for the STEM treatment protocol for persons with MS due to the methodologically rigorous study design. Finally, the currently proposed work is well grounded in a long line of memory rehabilitation work at KF led by the current PI and represents the next systematic step in the line of work examining strategy training. 1. National Center for Medical Rehabilitation Research (NCMRR): Overview. https://www.nichd.nih.gov/about/org/ncmrr/Pages/overview.aspx. Accessed September 14, 2017. 2. The Eunice Kennedy Shiver National Institute of Child Health and Human Development and the NIH Medical Rehabilitation Coordinating Committee. National Institutes of Health (NIH) Rehabilitation Plan on Rehabilitation: Moving the Field Forward. 2016. Accessed September 14, 2017.

项目摘要 新的学习和记忆障碍在多发性硬化症（MS）中很常见， 日常生活的几个方面，包括职业和社会功能。尽管学习的需求 和记忆治疗，迄今为止，只有少数认知康复（CR）方案得到I类研究的支持。 证据，从而限制了可能有效的治疗方法应用于MS的程度。 为了满足这一关键需求，目前提出的随机临床试验（RCT）检查了8个疗程的CR方案的有效性，该方案包括三种策略（自我生成，间隔 学习和自我测试）的最大经验证据，以治疗学习和记忆障碍的人 MS，Strategy-based Training to Enhance Memory（STEM），基于策略的记忆训练。目前拟定的双盲安慰剂对照随机临床试验（RCT）解决了2016年NCMRR中强调的中心目标 研究计划，力求减少“与残疾有关的症状和继发性疾病 通过制定、调整或评估干预措施”（第1531页）。 我们将进行一项双盲、安慰剂对照的随机对照试验，对120名MS参与者进行STEM治疗 证明NLM缺陷的人。将通过3种机制评估结果，即全球功能评估 (AGF)，检查日常功能和生活质量，神经心理学评估（NPE）， 检查客观认知表现，神经影像学，以阐明STEM及其 机制等将日常生活活动检查作为本RCT的先验终点是一项高度创新的研究。 目前拟议的工作的一个方面，强调作为一个显着的差距，在康复文献的 NCMRR 1。我们还将评估STEM对日常功能和NPE的长期疗效。 通过6个月的随访评估，评估加强治疗对维持治疗的影响 随着时间的推移效果。重要的是，目前研究中采用的严格的研究设计高度响应于 NCMRR在其最新研究计划中提出的目标，即“提高证据质量 康复干预.通过更加注重这些措施的设计.和结果， 干预”（第152页）。这种“基于证据的方法对康复研究至关重要” （NCMRR，20162） 在强有力的初步数据的支持下，这种新颖和创新的干预措施有可能显着改善 修复MS患者的NLM缺陷，最终改善社会和职业功能 (i.e.,参与）和总体QOL。目前的研究结果将为STEM提供I类证据 由于方法学上严格的研究设计，MS患者的治疗方案。最后，目前 拟议的工作是很好地建立在一个长期的记忆康复工作在KF领导的目前PI和 这是战略培训审查工作的下一个系统步骤。 1.国家医疗康复研究中心（NCMRR）：概述。 https://www.nichd.nih.gov/about/org/ncmrr/Pages/overview.aspx. 2017年9月14日访问。 2. Eunice Kennedy Shiver国家儿童健康和人类发展研究所和NIH 医疗康复协调委员会。美国国立卫生研究院（NIH）康复计划 关于康复：推动领域向前发展。2016. 2017年9月14日访问。