Charvet Leigh E, Yang Jie, Shaw Michael T, Sherman Kathleen, Haider Lamia, Xu Jianjin, Krupp Lauren B
Department of Neurology, NYU School of Medicine, New York, New York, United States of America.
Department of Family, Population, and Preventive Medicine, Stony Brook Medicine, New York, New York, United States of America.
PLoS One. 2017 May 11;12(5):e0177177. doi: 10.1371/journal.pone.0177177. eCollection 2017.
Cognitive impairment affects more than half of all individuals living with multiple sclerosis (MS). We hypothesized that training at home with an adaptive online cognitive training program would have greater cognitive benefit than ordinary computer games in cognitively-impaired adults with MS. This was a double-blind, randomized, active-placebo-controlled trial. Participants with MS were recruited through Stony Brook Medicine and randomly assigned to either the adaptive cognitive remediation (ACR) program or active control of ordinary computer games for 60 hours over 12 weeks. Training was remotely-supervised and delivered through a study-provided laptop computer. A computer generated, blocked stratification table prepared by statistician provided the randomization schedule and condition was assigned by a study technician. The primary outcome, administered by study psychometrician, was measured by change in a neuropsychological composite measure from baseline to study end. An intent-to-treat analysis was employed and missing primary outcome values were imputed via Markov Chain Monte Carlo method. Participants in the ACR (n = 74) vs. active control (n = 61) training program had significantly greater improvement in the primary outcome of cognitive functioning (mean change in composite z score±SD: 0·25±0·45 vs. 0·09±0·37, p = 0·03, estimated difference = 0·16 with 95% CI: 0·02-0·30), despite greater training time in the active control condition (mean±SD:56·9 ± 34·6 vs. 37·7 ±23 ·8 hours played, p = 0·006). This study provides Class I evidence that adaptive, computer-based cognitive remediation accessed from home can improve cognitive functioning in MS. This telerehabilitation approach allowed for rapid recruitment and high compliance, and can be readily applied to other neurological conditions associated with cognitive dysfunction.
Clinicaltrials.gov NCT02141386.
认知障碍影响着超过一半的多发性硬化症(MS)患者。我们假设,对于患有MS的认知障碍成年人,使用适应性在线认知训练程序在家中进行训练,比普通电脑游戏具有更大的认知益处。这是一项双盲、随机、活性安慰剂对照试验。通过石溪医学中心招募了MS患者,并将他们随机分配到适应性认知康复(ACR)计划组或普通电脑游戏活性对照组,在12周内进行60小时的训练。训练由远程监督,并通过研究提供的笔记本电脑进行。由统计学家准备的计算机生成的分组分层表提供随机化时间表,由研究技术员分配条件。主要结果由研究心理测量师进行评估,通过从基线到研究结束时神经心理学综合测量的变化来衡量。采用意向性分析,并通过马尔可夫链蒙特卡罗方法估算缺失的主要结果值。ACR训练计划组(n = 74)与活性对照组(n = 61)相比,在认知功能的主要结果方面有显著更大的改善(综合z评分的平均变化±标准差:0·25±0·45 vs. 0·09±0·37,p = 0·03,估计差异 = 0·16,95%置信区间:0·02 - 0·30),尽管活性对照组的训练时间更长(平均±标准差:玩游戏56·9 ± 34·6小时 vs. 37·7 ±23·8小时,p = 0·006)。这项研究提供了I类证据,表明在家中进行的适应性计算机辅助认知康复可以改善MS患者的认知功能。这种远程康复方法允许快速招募和高依从性,并且可以很容易地应用于与认知功能障碍相关的其他神经系统疾病。
Clinicaltrials.gov NCT02141386。