Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.
Royal Holloway, University of London, Egham, UK.
Mult Scler. 2021 Apr;27(5):778-789. doi: 10.1177/1352458520930371. Epub 2020 Jun 25.
To assess whether a videogame-like digital treatment is superior to a control in improving processing speed in adults with multiple sclerosis (MS).
Adults with MS and baseline Symbol Digit Modalities Test (SDMT) -scores between -2 and 0 were enrolled in a double-blind randomized controlled clinical trial. After completing a baseline in-clinic evaluation (Visit 1), they were randomized to complete an in-home, tablet-based videogame-like digital treatment (AKL-T03) or control word game (AKL-T09) for up to 25 minutes/day, 5 days/week, for 6 weeks. A repeat in-clinic evaluation occurred at 6 weeks (Visit 2), and again 8 weeks later to determine persistence of effects (Visit 3). The pre-specified primary outcome was change in SDMT score between Visits 1 and 2.
SDMT increased at Visit 2 for participants randomized to both AKL-T03 ( < 0.001) and AKL-T09 ( = 0.024). These respective mean improvements were +6.10 and +3.55 (comparison = 0.21). At Visit 3, 70% of participants randomized to AKL-T03 maintained a clinically meaningful 4+-point increase in SDMT above their baseline, compared with 37% for AKL-T09 ( = 0.038).
This in-home digital intervention resulted in substantial and durable improvements in processing speed. A larger randomized controlled clinical trial is planned.
This trial is registered on ClinicalTrials.gov under "NCT03569618," https://clinicaltrials.gov/ct2/show/NCT03569618.
评估类似视频游戏的数字疗法是否优于对照干预,从而改善多发性硬化症(MS)成人的处理速度。
入组时基线符号数字模态测试(SDMT)得分在-2 到 0 之间的 MS 成人患者,参加了一项双盲随机对照临床试验。完成门诊基线评估(第 1 次就诊)后,他们被随机分配完成家庭内基于平板电脑的类似视频游戏的数字治疗(AKL-T03)或对照文字游戏(AKL-T09),每天 25 分钟,每周 5 天,持续 6 周。第 6 周进行门诊重复评估(第 2 次就诊),8 周后再次评估以确定疗效的持久性(第 3 次就诊)。主要结局是第 1 次就诊和第 2 次就诊之间的 SDMT 评分变化。
AKL-T03( < 0.001)和 AKL-T09( = 0.024)随机分配的参与者在第 2 次就诊时 SDMT 均有增加。这些相应的平均改善分别为+6.10 和+3.55(比较 = 0.21)。第 3 次就诊时,70%随机分配至 AKL-T03 的参与者保持了有临床意义的 4+点以上的 SDMT 基线增加,而 AKL-T09 为 37%( = 0.038)。
这种家庭内数字干预可显著且持久地改善处理速度。计划进行更大规模的随机对照临床试验。
本试验在 ClinicalTrials.gov 上注册为“NCT03569618”,网址为 https://clinicaltrials.gov/ct2/show/NCT03569618。