The effect of repetitive transcranial magnetic stimulation (rTMS) on perioperative neurocognitive disorders in patients after cardiac surgery: study protocol for a randomized controlled trial.
Jing Wang, Xuyang Wang, Sijie Li, Jinrong Yang, Xiang Yan, Jie Gao, Xiuqin Jia, Long Zuo, Anshi Wu, Changwei Wei
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引用次数: 0
Abstract
Introduction: Perioperative neurocognitive disorders (PND) is one of the most common postoperative complications among elderly patients (above 65 years old) undergoing cardiac surgery. However, thus far, there have not been any effective therapies for managing PND. Recent research has shown that repetitive transcranial magnetic stimulation (rTMS) alters brain plasticity and improves cognitive function in several neurodegenerative disorders and psychiatric disorders. However, the potential benefits of rTMS in reducing PND in patients undergoing cardiac surgery have not been investigated. Therefore, the current protocol is designed to determine whether rTMS can reduce the incidence of PND in patients undergoing cardiac surgery.
Methods and analysis: The study will be a single-blinded, randomized controlled trial. Participants undergoing elective cardiac surgery will be randomized to receive either rTMS or sham stimulation with focal figure-of-eight coils over the right dorsolateral prefrontal cortex. A series of neuropsychological tests will be completed to evaluate cognitive function in surgery patients before, on day 7, and on day 30 after cardiac surgery. The primary outcome is the prevalence of PND in cardiac surgery patients. The secondary outcomes will be the incidence of postoperative delirium, pain, sleep quality, depressive symptoms, activities of daily living, length of hospital stay and ICU length of stay, and rate of complication and mortality during the hospital stay.
Ethics and dissemination: Beijing Chaoyang Hospital Ethics Committee approved this study and has the number 2022-ke-487. It is registered with Clinical Trials (trial number NCT05668559). Informed consent must be provided by all participants. The study result will be published in a peer-reviewed journal.
Trial registration: NCT05668559. Registered on June 6, 2022.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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