Department of Shanghai Institute of Health Sciences, Shanghai University of Traditional Chinese Medicine, No.1200 Cailun Road, Pudong New Area, Shanghai, 201203, China.
School of Exercise and Health, Shanghai University of Sport, Yangpu District, No.399 Changhai Road, Shanghai, 200438, China.
Trials. 2023 Jul 27;24(1):478. doi: 10.1186/s13063-023-07491-x.
Although increasing evidence suggests that repetitive transcranial magnetic stimulation may help improve cognitive impairment after stroke, its clinical efficacy is still limited. This limitation may be due to the fact that the left dorsolateral prefrontal cortex (DLPFC) is only one of several brain areas involved in post-stroke cognitive impairment (PSCI). The aim of the present study is to reveal whether dual-target stimulation is superior to single-target stimulation and usual care in the treatment of PSCI.
A single-center, single-blind, randomized controlled trial will be conducted, and fifty-seven PSCI patients will be recruited and randomly assigned to one of three groups based on the stimulating site. The primary outcome is cognitive function, measured using the Montreal Cognitive Assessment Beijing Version (MoCA-BJ) and Mini-Mental Status Examination (MMSE). The secondary outcomes are the modified Barthel Index (MBI), Trail-Making Test (TMT), and digital span test (DST). Furthermore, changes in brain activity are assessed using transcranial Doppler sonography (TCD) examination and serum levels of brain-derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF) closely related to nerve and vascular repair after brain injury. All outcomes will be measured at baseline and 4 weeks after treatment.
If dual-target rTMS in significant improvements in cognitive function, this method could be considered as a first-line clinical treatment for PSCI. This proposed study has the potential to identify a new, evidence-based intervention that can enhance cognition and independent living in patients with cognitive impairment after stroke.
Chinese Clinical Trial Registry ChiCTR2200066184 . It was registered on 26 November 2022.
尽管越来越多的证据表明重复经颅磁刺激可能有助于改善卒中后认知障碍，但它的临床疗效仍然有限。这种局限性可能是由于左背外侧前额叶皮层（DLPFC）仅是几个与卒中后认知障碍（PSCI）相关的脑区之一。本研究旨在揭示双靶点刺激是否优于单靶点刺激和常规护理治疗 PSCI。
将进行一项单中心、单盲、随机对照试验，招募 57 例 PSCI 患者，并根据刺激部位将其随机分为三组。主要结局是使用蒙特利尔认知评估北京版（MoCA-BJ）和简易精神状态检查（MMSE）测量的认知功能。次要结局是改良巴氏指数（MBI）、连线测试（TMT）和数字跨度测试（DST）。此外，通过经颅多普勒超声（TCD）检查和与神经和血管损伤后修复密切相关的血清脑源性神经营养因子（BDNF）和血管内皮生长因子（VEGF）水平评估脑活动的变化。所有结局均在基线和治疗 4 周后进行测量。
如果双靶点 rTMS 显著改善认知功能，这种方法可被视为 PSCI 的一线临床治疗方法。该研究有可能确定一种新的、基于证据的干预措施，可增强卒中后认知障碍患者的认知功能和独立生活能力。
中国临床试验注册中心 ChiCTR2200066184。于 2022 年 11 月 26 日注册。
