Returning to Everyday Tasks Utilizing Rehabilitation Networks-III Pilot Randomized Clinical Trial (RETURN-III Pilot RCT)

利用康复网络恢复日常任务-III试点随机临床试验（RETURN-III试点RCT）

• 批准号: 10663935
• 负责人: E Wesley ELY
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10663935
• 关键词: Acceleration; Admission activity; Affect; Air; Alzheimer' s Disease; American; Anatomy; Automobile Driving; Award; Blinded; Brain; Brain Injuries; Caring; Case Series; Cerebrovascular Circulation; Cessation of life; Chronic; Cognition; Cognitive; Critical Illness; Data; Dementia; Diagnosis; Dose; Education; Elderly; Employment; Enrollment; Epidemiology; Episodic memory; Executive Dysfunction; Functional disorder; Funding; Healthcare Systems; Hospitals; Hour; Image; Impaired cognition; Impairment; Incidence; Independent Living; Intensive Care Units; Intervention; Life; Magnetic Resonance Imaging; Measures; Medical; Medication Management; Medicine; Memory; Methods; Neuronal Plasticity; Neuropsychology; Operative Surgical Procedures; Outcome; Patients; Phase; Process; Protocols documentation; Public Health; Randomized; Randomized, Controlled Trials; Rehabilitation therapy; Research; Research Personnel; Research Training; Resources; Risk Factors; Severities; Short-Term Memory; Signal Transduction; Structure; Surgical Intensive Care; Survivors; Tablets; Technology; Tennessee; Testing; Time; Training Programs; Translating; Traumatic Brain Injury; United States Department of Veterans Affairs; Veterans; Work; active duty; aging brain; arterial spin labeling; blood oxygenation level dependent response; brain dysfunction; brain research; cerebral atrophy; clinical center; cognitive rehabilitation; computer game; computerized; effectiveness evaluation; executive function; healing; improved; innovation; marine; novel; portability; primary outcome; processing speed; randomized, clinical trials; rehabilitation strategy; survivorship

Of the millions of patients who live through critical illness annually, Intensive Care Unit (ICU) survivorship is marked by a dementia-like brain injury called post-ICU long-term cognitive impairment (ICU-LTCI) that creates grave difficulties with managing medications, handling finances, living independently, and maintaining employment. Data from our group and others show that 50% of ICU survivors suffer from ICU-LTCI and that the number of veterans who develop ICU-LTCI is as high as the number of patients with new traumatic brain injury diagnoses among all Active Duty, National Guard, and Reserves. Our pilot randomized “Returning to Everyday Tasks Utilizing Rehabilitation Networks-I” (RETURN-I) study showed that a 12-week cognitive rehabilitation intervention (versus controls) improved executive dysfunction. We then transformed this non-computerized resource- intensive strategy into a novel, efficient, and scalable Computerized Cognitive Rehabilitation (CCR) approach. This plasticity-based adaptive CCR was applied to ICU survivors enrolled in our uncontrolled case-series (RETURN-II) that signaled improvements across multiple cognitive domains. Building on nearly two decades of aging brain research with the VA-Tennessee Valley Healthcare System Geriatric Research, Education and Clinical Center (VA-TVHS GRECC), we propose this randomized controlled trial to investigate the efficacy of CCR for survivors with ICU- LTCI. The RETURN-III Study will be the next logical data-driven approach to create real-world solutions for Veterans and civilians surviving critical illness with disabling ICU-LTCI. The RETURN-III Study will test the hypotheses that a 12-week CCR intervention in medical and surgical ICU survivors will reduce the severity of cognitive impairment (Aim 1), and result in Magnetic Resonance Imaging (MRI) changes of decreased brain atrophy, greater functional connectivity, and greater cerebral blood flow (Exploratory Aim 2). To test these hypotheses, the RETURN-III study will randomize 160 medical and surgical VA ICU survivors with documented ICU-LTCI up to 14 days post-hospital discharge to either 12-weeks of intervention using CCR (n=80) vs. control of non-specific computer games (n=80). At 3, 6, and 12 months post-randomization, trained research personnel blinded to group assignment will use a validated battery to assess global cognition [primary outcome] (Aim 1: domains of processing speed, working memory, episodic memory, executive function), and to investigate 12-month MRI imaging metrics [exploratory outcome] (Aim 2: standard structural and anatomic protocols, baseline blood oxygenation level dependent responses, pseudo-continuous arterial spin labeling).

每年有数百万患有危重疾病的患者中，重症监护病房 (ICU) 幸存者的标志是类似痴呆症的脑损伤，称为重症监护病房后长期认知障碍 （ICU-LTCI）给管理药物、处理财务、生活造成严重困难 我们组和其他人的数据显示，50% 的 ICU 患者是独立的，并保持就业。 幸存者患有 ICU-LTCI，并且患有 ICU-LTCI 的退伍军人人数高达 全国现役军人中新诊断出创伤性脑损伤的患者人数 我们的试点随机“利用康复恢复日常任务”。 Networks-I”（RETURN-I）研究表明，为期 12 周的认知康复干预（与 然后我们改造了这种非计算机化的资源—— 将强化策略转化为新颖、高效且​​可扩展的计算机认知康复 (CCR) 这种基于可塑性的自适应 CCR 应用于我们的 ICU 幸存者。 不受控制的病例系列（RETURN-II）表明多个认知领域的改善。 以退伍军人管理局田纳西河谷近二十年的衰老大脑研究为基础 医疗保健系统老年研究、教育和临床中心 (VA-TVHS GRECC)，我们 提出这项随机对照试验来调查 CCR 对 ICU 幸存者的疗效 LTCI。RETURN-III 研究将是创建现实世界的下一个逻辑数据驱动方法。 为患有重病、无法使用 ICU-LTCI 的退伍军人和平民提供解决方案。 RETURN-III 研究将检验以下假设：为期 12 周的 CCR 干预 手术 ICU 幸存者将减轻认知障碍的严重程度（目标 1），并导致 磁共振成像 (MRI) 变化显示脑萎缩减少、功能增强 连接性和更大的脑血流量（探索性目标 2）。 为了检验这些假设，RETURN-III 研究将随机抽取 160 名内科和外科 VA 出院后 14 天至 12 周内记录有 ICU-LTCI 的 ICU 幸存者 使用 CCR 的干预 (n=80) 与非特定电脑游戏的控制 (n=80) 在 3、6 和 12 时。 随机化后几个月，训练有素的研究人员对分组分配不知情，将使用 经过验证的电池来评估全局认知[主要结果]（目标 1：处理领域 速度、工作记忆、情景记忆、执行功能），并研究 12 个月的 MRI 成像指标[探索性结果]（目标 2：标准结构和解剖协议、基线 血氧水平依赖性反应，伪连续动脉自旋标记）。

项目成果

Challenges of Delirium Management in Patients with Traumatic Brain Injury: From Pathophysiology to Clinical Practice.

创伤性脑损伤患者谵妄管理的挑战：从病理生理学到临床实践。

• 发表时间: 2021
• 影响因子: 5.3
• 作者: Roberson, Shawniqua Williams;Patel, Mayur B;Dabrowski, Wojciech;Ely, E Wesley;Pakulski, Cezary;Kotfis, Katarzyna
• 通讯作者: Kotfis, Katarzyna