Brain and behavior · 2025
The Therapeutic Effects of Acorus Tatarinowii Volatile Oil and Electroacupuncture in Post-Stroke Cognitive Impairment Patients: A Clinical Trial Protocol.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Dandan Ying, Jingting Zhao, Minzhe Wang, Zhuoyue Cai, Xinyun Li
Аннотация
BACKGROUND: Post-stroke cognitive impairment (PSCI) is a common complication following stroke, with limited effective treatments. This randomized controlled trial aims to evaluate the efficacy of two non-pharmacological interventions-electroacupuncture therapy (EA) and herbal olfactory therapy (HOT)-in improving cognitive function in PSCI patients, both as standalone treatments and in combination.
METHODS: This parallel-group, assessor-blinded, randomized controlled trial will recruit 210 PSCI patients, randomly assigned to one of six groups: control, EA, HOT, combination therapy, sham therapy, or the healthy (ratio 1:1:1:1:1:1). All participants will receive standard cognitive training and basic medical care. The EA group will receive 4 weeks of electro-acupuncture at specific acupoints. The HOT group will receive 4 weeks of aromatic inhalation therapy using Acorus tatarinowii volatile oil. The combination group will receive both interventions. The primary outcome measure is cognitive function, assessed using the Montreal cognitive assessment (MoCA) at baseline, week 4, and week 8. Secondary outcomes include the mini-mental state examination (MMSE), functional magnetic resonance imaging (fMRI), near-infrared spectroscopy (fNIRS), and anxiety assessment using the state-trait anxiety inventory (STAI) at baseline and week 4. Data analysis will be conducted using a modified intention-to-treat approach.
AIMS: This study aims to evaluate the clinical efficacy of EA at cervical acupoints combined with HOT for PSCI, with a specific focus on determining the therapeutic superiority of this combined approach over monotherapy interventions.
METHODS: This parallel-group, assessor-blinded, randomized controlled trial will recruit 210 PSCI patients, randomly assigned to one of six groups: control, EA, HOT, combination therapy, sham therapy, or the healthy (ratio 1:1:1:1:1:1). All participants will receive standard cognitive training and basic medical care. The EA group will receive 4 weeks of electro-acupuncture at specific acupoints. The HOT group will receive 4 weeks of aromatic inhalation therapy using Acorus tatarinowii volatile oil. The combination group will receive both interventions. The primary outcome measure is cognitive function, assessed using the Montreal cognitive assessment (MoCA) at baseline, week 4, and week 8. Secondary outcomes include the mini-mental state examination (MMSE), functional magnetic resonance imaging (fMRI), near-infrared spectroscopy (fNIRS), and anxiety assessment using the state-trait anxiety inventory (STAI) at baseline and week 4. Data analysis will be conducted using a modified intention-to-treat approach.
AIMS: This study aims to evaluate the clinical efficacy of EA at cervical acupoints combined with HOT for PSCI, with a specific focus on determining the therapeutic superiority of this combined approach over monotherapy interventions.