Efficacy of Acupuncture On Cognitive Function In Poststroke Depression: Study Protocol For A Randomized, Placebo-Controlled Trial

Abstract

Introduction: Poststroke depression (PSD) is the most common mental complication after stroke and has a serious impact on functional outcomes and quality of life. Antidepressants are the first-line treatment for PSD, but many reported side effects remain. Clinical research has shown that acupuncture has a positive effect on PSD. This trial aims to study the efficacy and safety of acupuncture for PSD and to explore its effect on cognitive function. It is hypothesized that acupuncture treatment improves depressive symptom, cognitive behavior and negative emotion processing bias in PSD.Methods: In this randomized, placebo-controlled, single-blinded trial, fifty-six people with PSD will be randomly allocated into the intervention (n=28) or control (n=28) groups. The intervention group will receive acupuncture treatment, and the control group will receive sham acupuncture treatment, in 20 sessions over 4 weeks. The primary outcome is the change from baseline in the Hamilton Depression Scale-17 (HAMD-17) scores at week 4. Secondary outcomes include the Wisconsin Card Sorting Test (WCST) and latency and amplitude of P1, N170 and P3 of the event-related potentials (ERPs) components to assess the changes in cognitive function and electroencephalography. Outcomes are assessed at baseline and post intervention.Discussion: Acupuncture therapy could become an alternative treatment for PSD, and it is expected that this trial will provide reliable clinical evidence for the future use of acupuncture for the treatment of PSD.Trial registration: Chinese Clinical Trial Registry: ChiCTR1900026948. Registered on 27 October 2019.