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The Effect of Electroacupuncture on Microcirculation in Patients With Hypertension and Cognitive Impairment: Protocol for a Multicenter Randomized Controlled Trial

AuthorsJian WenXInlei DongXiaolin ChenXiao LuoYuting WangYimeng GongOAKaixuan MaDongling ZhongOAQinfeng YanOAJuan LiLili ZhangOA
Year2025
VenueJMIR Research Protocols

Background: Hypertension is a significant risk factor for cardiovascular diseases and is associated with an increased risk of mild cognitive impairment (MCI). The lack of effective treatment for these conditions underscores the urgent need for novel therapeutic approaches. Previous studies have indicated that microcirculation serves as the pathological basis for the comorbidity of hypertension and cognitive dysfunction. Our initial clinical studies have indicated that acupuncture could be a safe and effective treatment for managing hypertension and MCI. Whether acupuncture can enhance hypertension and cognitive impairment by modulating microcirculation, and the precise mechanisms involved, warrants further exploration. Objective: The objective of the trial is to evaluate the clinical efficacy of electroacupuncture on MCI of patients with hypertension and to explore whether it can improve hypertension and cognitive impairment by regulating microcirculation. Methods: In this multicenter, large-scale, single-blind, randomized controlled trial, we will recruit 252 patients with hypertension and cognitive impairment from 3 hospitals and randomly assign them to 3 groups in a 1:1:1 ratio: the electroacupuncture group, the sham electroacupuncture (SEA) group, and the waiting list group. The electroacupuncture group and SEA group will receive either electroacupuncture or SEA for 12 weeks, while the waiting list group will not receive acupuncture treatment for the first 12 weeks. The primary outcome will be the changes in overall cognitive function, as measured by the Montreal Cognitive Assessment. The secondary outcomes include blood pressure status, subdomain cognitive function, mental status, sleep quality, hemodynamics, and microcirculation indicators. Results: The study protocol has been approved by the institutional review board of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine. This study was registered on April 26, 2024, with the Chinese Clinical Trial Registry. Data collection began in May 2024 and ended in April 2025. Currently, data from this trial are in the collection phase, and no data analysis has been performed. As of January 1, 2025, we have collected data from 65 patients. The results of this trial are expected to be submitted for publication in July 2026. Conclusions: This clinical trial aims to compare the efficacy of electroacupuncture versus SEA or waiting list control in the treatment of hypertension with cognitive impairment and to explore its impact on microcirculation through hemodynamic and microcirculatory indices. The results of this trial will contribute to clarifying the microcirculatory mechanisms of electroacupuncture in the treatment of hypertension with cognitive impairment, providing a solid foundation for further research on electroacupuncture therapy. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2400083501; https://www.chictr.org.cn/showproj.html?proj=220722

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