Cognitive Rehabilitation for Individuals with Parkinson's Disease and MCI

帕金森病和轻度认知障碍患者的认知康复

• 批准号: 9057388
• 负责人: Dawn M. Schiehser
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-11-01 至 2019-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9057388
• 关键词: Aftercare; Analysis of Covariance; Attenuated; Blinded; Caring; Cognition; Cognitive; Cognitive deficits; Control Groups; Controlled Study; Data; Dementia; Development; Diagnosis; Foundations; Goals; Health Status; Healthcare Systems; Impaired cognition; Individual; Institutes; Intervention; Investigation; Knowledge; Longevity; Measures; Mediating; Mediator of activation protein; Medical; Memory; Modeling; Moods; Movement Disorders; Neurobehavioral Manifestations; Neuropsychology; Parkinson Disease; Participant; Patients; Pharmacological Treatment; Phase; Phase Transition; Population; Psychosocial Stress; Quality of Care; Quality of life; Randomized; Recruitment Activity; Rehabilitation therapy; Research; Role; Severity of illness; Sleep; Societies; Supportive care; Techniques; Testing; United States Department of Veterans Affairs; Veterans; base; clinical care; cognitive change; cognitive function; cognitive rehabilitation; cognitive skill; disabling symptom; efficacy study; executive function; follow up assessment; follow-up; functional outcomes; group intervention; improved; intervention effect; mild cognitive impairment; motor symptom; neglect; neuropsychiatric symptom; novel; post intervention; prevent; primary outcome; programs; public health relevance; secondary analysis; skills training; symptom management; treatment effect

 DESCRIPTION: Cognitive deficits in Parkinson's disease (PD) are often progressive and frequently represent the most debilitating symptom that result in decreased functional outcome and quality of life (QoL). It is estimated that 20-50% of individuals with PD meet criteria for Mild Cognitive Impairment (PD-MCI), which is characterized as the transitional phase between normal cognition and dementia. Unfortunately, there are few pharmacologic treatment options to help with cognitive impairments associated with PD-MCI. Cognitive rehabilitation based on the development of compensatory strategies represents a non-pharmacological approach to improve cognition in PD-MCI. However, to our knowledge there are no studies examining this approach in PD, which is a critical gap in our knowledge. Moreover, neuropsychiatric symptoms (e.g. sleep difficulty, mood), common in PD, are often neglected in traditional interventions. Thus, the overall aim of this investigation is to determine the efficacy of a novel, manualized compensatory cognitive rehabilitation program to improve cognitive deficits as well as improve neuropsychiatric symptoms and quality of life/health status (QoL/HS) in individuals with PD-MCI. This program, Cognitive Symptom Management and Rehabilitation Therapy for Parkinson's Disease (CogSMART-PD), is a 10-week intervention that provides cognitive skills training and teaches compensatory strategies to help individuals with PD-MCI cope with and adapt to cognitive deficits. Also, the program provides psychosocial and stress-reducing techniques to attenuate common neuropsychiatric symptoms that often negatively impact cognitive functioning and QoL. Our preliminary data demonstrated that CogSMART-PD holds great promise for the treatment of cognitive and neuropsychiatric symptoms in PD-MCI. To our knowledge, this is the first proposed randomized, parallel, controlled study to investigate the efficacy of a compensatory cognitive rehabilitation program adapted specifically for PD. We hypothesize that cognitive functioning, neuropsychiatric symptoms, and quality of life/health status will improve in PD-MCI participants following 10 weeks of the CogSMART-PD, and these improvements will be maintained at 6- and 12-months post-treatment. One hundred ten participants with PD-MCI based on the criteria set forth by the Movement Disorder Society will be recruited for this study. Over-recruitment by 20% will be instituted to account for subject attrition or unusable data. Participants will be randomized into either a 10-week CogSMART-PD intervention group (n = 55) or 10-week supportive care group (n = 55). All participants will be assessed with a battery of tests that measure objective and subjective cognitive function, neuropsychiatric symptoms, disease severity, motor symptoms, and quality of life/health status by an examiner blinded to group assignment. Assessments will be administered at baseline, 10 weeks (post-treatment), and 6- and 12- months (follow-ups). Data will be primarily analyzed using analyses of covariance and linear random effects modeling. Results of this study will provide essential information about a non-pharmacological intervention for individuals with PD-MCI that could improve their cognition, neuropsychiatric symptoms, and quality of life/ health status. Moreover, these results may demonstrate the first evidence of preventing or stabilizing functional cognitive decline in PD and could provide a manualized and systematic program that can be feasibly implemented and disseminated throughout the VA Healthcare System.

 产品说明： 帕金森病（PD）的认知缺陷通常是进行性的，并且经常是导致功能结局和生活质量（QoL）下降的最具破坏性的症状。据估计，20-50%的PD患者符合轻度认知障碍（PD-MCI）的标准，其特征在于正常认知和痴呆之间的过渡阶段。不幸的是，几乎没有药物治疗选择可以帮助治疗与PD-MCI相关的认知障碍。基于补偿策略的认知康复是改善PD-MCI认知功能的非药物方法。然而，据我们所知，还没有研究在PD中检查这种方法，这是我们知识中的一个关键空白。此外，神经精神症状（如睡眠困难，情绪），常见的PD，往往被忽视在传统的干预措施。因此，本研究的总体目的是确定一种新型的手动补偿性认知康复计划在改善PD-MCI患者认知缺陷以及改善神经精神症状和生活质量/健康状况（QoL/HS）方面的疗效。该项目名为帕金森病认知症状管理和康复治疗（CogSMART-PD），是一项为期10周的干预措施，提供认知技能培训并教授补偿策略，以帮助PD-MCI患者科普和适应认知缺陷。此外，该计划提供心理社会和减压技术，以减轻常见的神经精神症状，往往对认知功能和生活质量产生负面影响。我们的初步数据表明，CogSMART-PD对治疗PD-MCI的认知和神经精神症状有很大的希望。据我们所知，这是第一个提出的随机，平行，对照研究，以探讨专门适用于PD的补偿性认知康复计划的疗效。我们假设，认知功能、神经精神症状和生活质量/健康状况将改善， PD-MCI参与者在CogSMART-PD治疗10周后，这些改善将在治疗后6个月和12个月维持。本研究将招募110名根据运动障碍协会制定的标准患有PD-MCI的参与者。将制定20%的超额招募，以解释受试者流失或不可用的数据。参与者将被随机分配到10周CogSMART-PD干预组（n = 55）或10周支持治疗组（n = 55）。所有受试者将由对分组设盲的检查者通过一系列测试进行评估，这些测试测量客观和主观认知功能、神经精神症状、疾病严重程度、运动症状和生活质量/健康状况。将在基线、10周（治疗后）以及6个月和12个月（随访）时进行评估。将主要使用协方差分析和线性随机效应模型分析数据。这项研究的结果将提供有关PD-MCI患者非药物干预的基本信息，这些干预可以改善他们的认知，神经精神症状和生活质量/健康状况。此外，这些结果可以证明预防或稳定PD功能性认知下降的第一个证据，并可以提供一个手动和系统的程序，可以在整个VA医疗保健系统中可行地实施和传播。