Comparing conventional treatment, single-target rTMS, or dual-target rTMS for the treatment of post-stroke cognitive impairment - clinical effects and neuroscientific insights: study protocol for a randomized controlled trial

比较常规治疗、单靶点rTMS或双靶点rTMS治疗卒中后认知障碍的疗效——临床效果和神经科学见解:一项随机对照试验的研究方案

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Abstract

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2200066184 . It was registered on 26 November 2022.

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