The Effect of electroacupuncture on microcirculation in hypertension patients with mild cognitive impairment: protocol for a multi-center randomized controlled trial (Preprint)
Authors: Wen Jian , Dong XInlei , Chen Xiaolin , Luo Xiao , Wang Yuting , Gong Yimeng , Ma Kaixuan , Zhong Dongling , Yan Qinfeng , Li Juan , Zhang Lili 
Published: January 2025

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 treatments 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 mild cognitive impairment. 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 electroacupunctureon mild cognitive impairment of hypertension patients and to explore whether it can improve hypertension and cognitive impairment by regulating microcirculation.

METHODS

In this multi-center, large-scale, single-blind, randomized controlled trial, a total of 252 patients with hypertension and cognitive impairment will be recruited from 3 hospitals and randomly assigned to three groups: electroacupuncture(EA) group, sham electroacupuncture(SEA) group, and waiting-list group in a 1:1:1 ratio. The EA group and SEA group will receive either electroacupuncture or sham electroacupuncture 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 (MoCA). 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 IRB of The First Affiliated Hospital of Tianjin University of TCM. This study was registered on April 26, 2024, with the Chinese Clinical Trial Registry. Data collection began on May 2024 and is expected to end on 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 sham electroacupuncture or waiting-list control in 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.

CLINICALTRIAL

The protocol has been approved by the IRB of The First Affiliated Hospital of Tianjin University of TCM(TYLL2023[6]051). Every participant will be informed of detailed information about the study before signing informed consent. The results of this trial will be published in a peer-reviewed journal.