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A Brain-Computer Interface Based Cognitive Training System for Healthy Elderly: A Randomized Control Pilot Study for Usability and Preliminary Efficacy

机译:基于脑-计算机接口的健康老年人认知训练系统:可用性和初步功效的随机对照试验研究

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摘要

Cognitive decline in aging is a pressing issue associated with significant healthcare costs and deterioration in quality of life. Previously, we reported the successful use of a novel brain-computer interface (BCI) training system in improving symptoms of attention deficit hyperactivity disorder. Here, we examine the feasibility of the BCI system with a new game that incorporates memory training in improving memory and attention in a pilot sample of healthy elderly. This study investigates the safety, usability and acceptability of our BCI system to elderly, and obtains an efficacy estimate to warrant a phase III trial. Thirty-one healthy elderly were randomized into intervention (n = 15) and waitlist control arms (n = 16). Intervention consisted of an 8-week training comprising 24 half-hour sessions. A usability and acceptability questionnaire was administered at the end of training. Safety was investigated by querying users about adverse events after every session. Efficacy of the system was measured by the change of total score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) before and after training. Feedback on the usability and acceptability questionnaire was positive. No adverse events were reported for all participants across all sessions. Though the median difference in the RBANS change scores between arms was not statistically significant, an effect size of 0.6SD was obtained, which reflects potential clinical utility according to Simon’s randomized phase II trial design. Pooled data from both arms also showed that the median change in total scores pre and post-training was statistically significant (Mdn = 4.0; p<0.001). Specifically, there were significant improvements in immediate memory (p = 0.038), visuospatial/constructional (p = 0.014), attention (p = 0.039), and delayed memory (p<0.001) scores. Our BCI-based system shows promise in improving memory and attention in healthy elderly, and appears to be safe, user-friendly and acceptable to senior users. Given the efficacy signal, a phase III trial is warranted.
机译:认知上的衰老下降是与重大医疗费用和生活质量下降相关的紧迫问题。以前,我们报道了一种新型的脑机接口(BCI)训练系统在改善注意力缺陷多动障碍症状方面的成功使用。在这里,我们通过一个新的游戏来检验BCI系统的可行性,该游戏结合了记忆训练来改善健康老年人的样本中的记忆和注意力。这项研究调查了我们的BCI系统对老年人的安全性,可用性和可接受性,并获得了需要进行III期临床试验的疗效评估。将31名健康老人随机分为干预组(n = 15)和候补控制组(n = 16)。干预包括为期8周的培训,包括24个半小时的课程。在培训结束时,将发布可用性和可接受性调查表。通过在每次会话后向用户查询不良事件来调查安全性。训练前后,通过评估神经心理状态的可重复电池(RBANS)的总得分的变化来衡量系统的功效。可用性和可接受性调查表的反馈是积极的。在所有会议期间,所有参与者均未报告不良事件。尽管两臂之间RBANS变化评分的中位数差异无统计学意义,但根据西蒙(Simon)的随机II期临床试验设计,其效应大小为0.6SD,反映了潜在的临床效用。双方的汇总数据还显示,训练前后总成绩的中位数变化具有统计学意义(Mdn = 4.0; p <0.001)。具体而言,即时记忆(p = 0.038),视觉空间/结构(p = 0.014),注意力(p = 0.039)和延迟记忆(p <0.001)得分都有显着改善。我们基于BCI的系统在改善健康老年人的记忆力和注意力方面显示出广阔的前景,并且似乎是安全的,用户友好的并且为高级用户所接受。鉴于疗效信号,必须进行III期试验。

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