STUDY PROTOCOL article
Front. Psychiatry
Sec. Mood Disorders
This article is part of the Research TopicNeuropsychiatric Symptoms in Parkinson’s DiseaseView all articles
Efficacy and Safety of Adjunctive Acupuncture for Depression and Motor Symptoms in Parkinson's Disease: Study Protocol for a Randomized Controlled Trial
Provisionally accepted
- 1Guangzhou University of Chinese Medicine, Guangzhou, China
- 2The First Affiliated Hospital of Guangzhou Unive, Guangzhou University of Chinese Medicine, Guangzhou, China
- 3Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital, Guangzhou, China
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Background Depression is one of the most prevalent and disabling non-motor symptoms in Parkinson's disease (PD), forming a bidirectional relationship with motor dysfunction that worsens quality of life. Pharmacological treatments exhibit limited and inconsistent efficacy, and may lead to adverse interactions. Acupuncture may improve both depressive and motor symptoms by regulating the neuro–immune–endocrine network, but high-quality evidence remains insufficient. Objective This study aims to evaluate the efficacy and safety of acupuncture as an adjunctive therapy for depression in PD and to explore potential biological correlates of clinical changes using predefined serum biomarkers. Methods In this single-center, evaluator-blinded, randomized controlled trial, 88 patients with PD and comorbid depression will be randomly assigned to an acupuncture group or a waitlist control group. The primary outcome is the change in the Montgomery–Asberg Depression Rating Scale (MADRS) score. Secondary outcomes include motor function, anxiety, sleep quality, and overall quality of life. Exploratory analyses will assess serum inflammatory cytokines, brain-derived neurotrophic factor (BDNF), and kynurenine/tryptophan (KYN/TRP) ratio. Expected Results We hypothesize that adjunctive acupuncture may improve depressive and motor symptoms compared with the control. Exploratory analyses will examine whether clinical changes are associated with changes in relevant biomarkers. Conclusion This study will provide rigorous evidence for acupuncture as an adjunctive therapy, offering a non-pharmacological strategy to optimize the comprehensive management of PD and disrupt the bidirectional emotion–motor interplay. Clinical trial registration Chinese Clinical Trial Registry: ChiCTR2500113443
Keywords: Acupuncture, Motor symptoms, Parkinson's disease, Parkinson's disease with depression, randomized controlled trial
Received: 04 Dec 2025; Accepted: 07 Jan 2026.
Copyright: © 2026 Liao, Fan, Xiao, Gu, Han, Nian, Wu and Zhuang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Lixing Zhuang
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