Department of Neurology, Torrecárdenas University Hospital, Almería, Spain,
Department of Psychology and Centre for Health Research (CEINSA), University of Almería, Almería, Spain.
Cerebrovasc Dis. 2024;53(3):335-345. doi: 10.1159/000531860. Epub 2023 Jul 20.
Research on the benefits of non-invasive brain stimulation in stroke patients to improve executive functions is scarce. The objective of this study was to investigate the effectiveness of transcranial direct current stimulation (tDCS) in combination with cognitive training for the rehabilitation of executive functions in acute and subacute stroke patients as well as to explore the underlying physiological mechanisms. A triple-blinded, randomized-controlled clinical trial will be conducted involving 60 stroke patients with frontal or basal ganglia lesions and a Montreal Cognitive Assessment (MoCA) score less than 26. Participants will be randomly assigned to receive active tDCS (anode over the left dorsolateral prefrontal cortex, cathode at the right supraorbital region, 20 min at 2 mA) or sham tDCS in a 1:1 ratio for 10 sessions, followed by targeted executive function training. The primary efficacy outcome will be the MoCA score, while secondary outcomes will include the five-digit test (inhibitory control), the Digit Span Task (working memory), the abbreviated version of the Wisconsin Card Sorting test (cognitive flexibility), modified Rankin scale (functional state), Beck-II depression inventory, apathy evaluation scale, and the WHOQOL-BREF (quality of life), assessed immediately after the intervention and at 1, 3, 6, and 12 months post-intervention. Additionally, resting-state functional connectivity and blood biomarkers, such as neurotrophins, growth factors, and inflammatory molecules, will be evaluated before and after the intervention. This study will contribute to the investigation of the efficacy of tDCS in rehabilitating executive functions in acute and subacute stroke patients. The multidimensional approach utilized in this study, which includes analysis of resting-state connectivity and neuroplasticity-related blood biomarkers, is expected to provide insights into the underlying brain mechanisms involved in the rehabilitation of dysexecutive syndrome.
关于非侵入性脑刺激在改善中风患者执行功能方面的益处的研究很少。本研究旨在探讨经颅直流电刺激（tDCS）联合认知训练对急性和亚急性中风患者执行功能康复的有效性，并探讨潜在的生理机制。一项三盲、随机对照临床试验将纳入 60 名额叶或基底节病变且蒙特利尔认知评估（MoCA）评分<26 的中风患者。参与者将以 1:1 的比例随机分为真刺激 tDCS（阳极置于左背外侧前额叶，阴极置于右眶上区，2 mA 20 分钟）或假刺激 tDCS 组，共 10 次，然后进行有针对性的执行功能训练。主要疗效指标为 MoCA 评分，次要疗效指标包括五位数测试（抑制控制）、数字跨度测试（工作记忆）、威斯康星卡片分类测试简短版（认知灵活性）、改良 Rankin 量表（功能状态）、贝克抑郁量表第二版（抑郁）、淡漠评估量表和世界卫生组织生活质量简表（生活质量），在干预后即刻以及干预后 1、3、6 和 12 个月进行评估。此外，还将在干预前后评估静息态功能连接和神经生物标志物，如神经递质、生长因子和炎症分子。本研究将有助于研究 tDCS 对急性和亚急性中风患者执行功能康复的疗效。本研究采用的多维方法，包括静息态连接和神经可塑性相关血液生物标志物的分析，有望深入了解与执行功能障碍综合征康复相关的潜在大脑机制。
