Abstract
IntroductionPoststroke 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 symptoms, cognitive behavior, and negative emotion processing bias in PSD.MethodsIn 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.DiscussionAcupuncture 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 registrationChinese Clinical Trial Registry ChiCTR1900026948. Registered on 27 October 2019.
Highlights
Poststroke depression (PSD) is the most common mental complication after stroke and has a serious impact on functional outcomes and quality of life
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
Acupuncture is recommended as a promising nonpharmaceutical therapy for major depressive disorder (MDD)
Summary
Study setting This randomized, placebo-controlled, single-blinded trial will recruit 56 stroke survivors with depression. This study will be conducted at the Department of Acupuncture of The Secondary Medical College of Guangzhou University of Traditional Chinese Medicine, China. The participating physicians in the trial are acupuncture doctors at the Secondary Medical College of Guangzhou University of Traditional Chinese Medicine. In the sham acupuncture group, placebo needles with a blunt tip (0.3 × 40 mm; Suzhou Tianxie Acupuncture Instruments Co., Ltd., Suzhou City, China) and sterile adhesive pads will be used Those non-invasive placebo devices have been applied in published randomized controlled trials (RCTs) to minimize the physiological effects of skin penetratio n[21]. Data collection methods Before study initiation, all researchers and acupuncturists will participate in a 2-day training session including assessment and collection of outcome, baseline, and follow-up organized by the Secondary Medical College of Guangzhou University of Traditional Chinese Medicine. All participants will be reimbursed for travel expenses to encourage adherence during the follow-up phase
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
