Bove Riley M, Rush Gillian, Zhao Chao, Rowles William, Garcha Priya, Morrissey John, Schembri Adrian, Alailima Titi, Langdon Dawn, Possin Katherine, Gazzaley Adam, Feinstein Anthony, Anguera Joaquin
Department of Neurology, Weill Institute for the Neurosciences, University of California, San Francisco, USA.
Cogstate, Inc., Melbourne, Australia.
Neurol Ther. 2019 Jun;8(1):135-145. doi: 10.1007/s40120-018-0121-0. Epub 2018 Nov 30.
Self-administered in-home digital therapeutics could expand access to cognitive rehabilitation for individuals with multiple sclerosis (MS), over half of whom experience cognitive impairment (CI). However, feasibility in an MS population must be clarified. This study was conducted to assess the feasibility of deploying a videogame-like digital treatment for CI in MS, including initial efficacy and barriers to adherence.
In this pilot study, 21 participants with MS completed an in-clinic baseline neurological evaluation. Cognitive tests included paper-and-pencil Brief International Cognitive Assessment for Multiple Sclerosis [BICAMS-which included the Symbol Digit Modalities Test (SDMT)] and other unsupervised tablet-based tests (including Match: an unsupervised test of executive functions and processing speed, developed at UCSF; and the Cogstate MS Battery). Participants then completed an in-home, tablet-based, videogame-like investigational digital treatment (Project: EVO™) for 25 min daily, 5 days weekly, for 4 weeks. This was followed by a repeat in-clinic evaluation.
Of the 21 participants (mean [standard deviation, SD] age 53.8 [11.6] years, median Expanded Disability Status Scale (EDSS) 2.5 [SD 2.0, IQR [2-3.5]]) enrolled to use the digital therapeutic at home (mean [SD] SDMT z score: - 0.21 [1.16]), 18 completed the study, during which they completed an average of 19.7 days (median [SD]: 20.5 [8.4]). Overall, 78% of these 18 participants completed 75% of prescribed days (i.e., at least 15), and 50% completed all 20 days or more. Over the 4-week period, scores of processing speed improved significantly (based on one-sided t test), including SDMT (p = 0.003) and Match (p = 0.006). The Cogstate DET test (psychomotor function) also increased (p = 0.006). Mean increase in SDMT was 3.6 points. Male sex, not being employed, and higher baseline anxiety all were significantly associated with greater improvement in SDMT over the 4-week period. Interestingly, lower baseline cognitive scores were associated with greater number of sessions completed (e.g., SDMT: p = 0.003, R = 0.44). Adjusting for employment, a proxy for time available, did not significantly improve the model fit.
Deploying an in-home digital tool to improve processing speed in MS is feasible, and shows preliminary efficacy. A larger, randomized controlled clinical trial is ongoing.
自我管理的家庭数字疗法可为多发性硬化症（MS）患者提供更多获得认知康复治疗的机会，超过半数的MS患者存在认知障碍（CI）。然而，该疗法在MS患者群体中的可行性尚需明确。本研究旨在评估一种类似电子游戏的数字疗法用于MS患者CI治疗的可行性，包括初始疗效及依从性障碍。
在这项试点研究中，21名MS患者完成了门诊基线神经学评估。认知测试包括纸笔形式的多发性硬化症简明国际认知评估量表[BICAMS，其中包括符号数字模式测验（SDMT）]以及其他基于平板电脑的非监督测试（包括Match：一种由加州大学旧金山分校开发的执行功能和处理速度的非监督测试；以及Cogstate MS成套测验）。参与者随后在家中通过平板电脑完成一种类似电子游戏的研究性数字疗法（项目：EVO™），每天25分钟，每周5天，共4周。之后进行重复的门诊评估。
21名在家中使用数字疗法的参与者（平均[标准差，SD]年龄53.8[11.6]岁，扩展残疾状态量表（EDSS）中位数2.5[SD 2.0，四分位数间距[2 - 3.5]]）（平均[SD]SDMT z分数： - 0.21[1.16]），18名完成了研究，在此期间他们平均完成了19.7天（中位数[SD]：20.5[8.4]）。总体而言，这18名参与者中有78%完成了规定天数的75%（即至少15天），50%完成了全部20天及以上。在4周期间，处理速度得分显著提高（基于单侧t检验），包括SDMT（p = 0.003）和Match（p = 0.006）。Cogstate DET测试（精神运动功能）也有所增加（p = 0.006）。SDMT平均提高了3.6分。男性、未就业以及较高的基线焦虑水平均与4周期间SDMT的更大改善显著相关。有趣的是，较低的基线认知得分与完成的疗程数较多相关（例如，SDMT：p = 0.003，R = 0.44）。将就业情况作为可用时间的替代指标进行调整后，并未显著改善模型拟合度。
在家中部署数字工具以提高MS患者的处理速度是可行的，并显示出初步疗效。一项更大规模的随机对照临床试验正在进行中。
