基于远程医疗的经颅直流电刺激改善多发性硬化症患者的认知结果：一项假对照随机对照试验的结果
Enhanced cognitive outcomes with telehealth-based tDCS in multiple sclerosis: Results from a sham-controlled RCT.
作者信息
Charvet Leigh, Goldberg Judith, Li Xiaochun, Best Pamela, Shaw Michael, Ryerson Lana Zhovtis, Gutman Josef, Bikson Marom, Pilloni Giuseppina, Krupp Lauren
机构信息
Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA.
Division of Biostatistics, Department of Population Health, NYU Grossman School of Medicine, New York, NY, USA.
出版信息
Mult Scler J Exp Transl Clin. 2025 Jul 28;11(3):20552173251356704. doi: 10.1177/20552173251356704. eCollection 2025 Jul-Sep.
BACKGROUND
Cognitive impairment is common in multiple sclerosis (MS). Transcranial direct current stimulation (tDCS) combined with adaptive cognitive training (aCT) may improve clinical outcomes.
OBJECTIVE
To evaluate the effect of active vs. sham home-based tDCS + aCT on cognitive function.
METHODS
Participants with MS and fatigue, without depression or severe cognitive impairment, were randomized to complete 30 remotely supervised 20-minute sessions of active (2.0 mA) or sham tDCS targeting the left anodal dorsolateral prefrontal cortex, paired with aCT. Randomization was stratified by high (H) vs. low (L) EDSS. The Brief International Cognitive Assessment in MS (BICAMS) was administered at baseline and intervention end, with scores converted to demographics-adjusted -scores.
RESULTS
Out of 117 participants, 106 completed BICAMS assessments. Compliance was high; 92% completed >25 sessions. Mean change in BICAMS -score was significantly greater in the active ( = 55: 0.06 ± 0.56) versus sham ( = 51: -0.16 ± 0.50) group ( = 0.035). The interaction between treatment and EDSS for BICAMS -score was not significant ( = .254), but benefits were greater in H EDSS (-0.00 ± 0.57 vs. -0.37 ± 0.39; = .022) than L EDSS (0.11 ± 0.56 vs. -0.01 ± 0.53; = .411).
CONCLUSIONS
Active vs. sham tDCS + aCT resulted in significantly better cognitive outcomes, with the greatest benefit in those with high neurologic disability.CLINICALTRIALS.GOV; https://clinicaltrials.gov/study/NCT03838770; IDENTIFIER: NCT03838770.
背景
认知障碍在多发性硬化症（MS）中很常见。经颅直流电刺激（tDCS）联合适应性认知训练（aCT）可能会改善临床结果。
目的
评估主动式与假刺激的家庭式tDCS + aCT对认知功能的影响。
方法
患有MS且有疲劳症状、无抑郁或严重认知障碍的参与者被随机分配，完成30次由远程监督的20分钟疗程，对左侧阳极背外侧前额叶皮层进行主动式（2.0 mA）或假刺激tDCS，并配合aCT。随机分组按扩展残疾状态量表（EDSS）高（H）与低（L）分层。在基线和干预结束时进行多发性硬化症简易国际认知评估（BICAMS），分数转换为经人口统计学调整的分数。
结果
117名参与者中，106名完成了BICAMS评估。依从性很高；92%的人完成了超过25次疗程。主动式组（n = 55：0.06±0.56）的BICAMS分数平均变化显著大于假刺激组（n = 51：-0.16±0.50）（P = 0.035）。治疗与EDSS对BICAMS分数的交互作用不显著（P = 0.254），但高EDSS组的获益更大（-0.00±0.57对-0.37±0.39；P = 0.022），高于低EDSS组（0.11±0.56对-0.01±0.53；P = 0.411）。
结论
主动式与假刺激tDCS + aCT产生了显著更好的认知结果，对神经功能残疾程度高的人获益最大。临床试验注册；https://clinicaltrials.gov/study/NCT03838770；标识符：NCT03838770。
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