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STUDY PROTOCOL article

Front. Neurol.
Sec. Experimental Therapeutics
Volume 15 - 2024 | doi: 10.3389/fneur.2024.1457787
This article is part of the Research Topic Alternative and Complementary Therapies to Promote Mental Health and Wellbeing for Older Adults - Volume II View all articles

Acupuncture for early Parkinson's disease with mild to moderate depression a randomized controlled trial protocol with functional MRI

Provisionally accepted
Hongli Xiao Hongli Xiao 1Yashuo Ren Yashuo Ren 1*Haosen Yang Haosen Yang 1*Zixi Wang Zixi Wang 2*Zhuohao Li Zhuohao Li 2Yuguo Song Yuguo Song 1*Xiaojia Yuan Xiaojia Yuan 1*Xiaopeng Liu Xiaopeng Liu 1*Peng Chen Peng Chen 3*
  • 1 Beijing University of Chinese Medicine, Beijing, China
  • 2 Capital Medical University, Beijing, Beijing Municipality, China
  • 3 Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Beijing, China

The final, formatted version of the article will be published soon.

    ABSTRACT Introduction Depression is a common non-motor symptom of Parkinson's disease (PD), which seriously affects the quality of life of patients with PD. The main clinical treatment method for depression in Parkinson's disease is medication treatment. However, the medication treatment has a long cycle and many adverse reactions. Acupuncture as a non-pharmacological intervention method, has been widely used in the treatment of patients with Parkinson's disease and depressive disorders in China. Therefore, the study of acupuncture in the treatment of early Parkinson's disease with mild to moderate depression has important practical significance. Methods and analysis In this randomized, single-blinded, and placebo-controlled study, a total of 88 patients with Depression in Parkinson’s disease (DPD) will be randomly allocated to either an acupuncture group or a control group in parallel in a 1:1 allocation ratio. Each group will receive 30 min acupuncture treatments or sham acupuncture treatments, 3 times a week, for 12 weeks, followed by a 36-week follow-up period. The primary outcome is the response rate of the Hamilton Depression Scale-17 at 12 weeks. Data will be collected at baseline, at the end of the 12-week treatment period, and during the 12-week and 36-week follow-up. Discussion This study hypothesized that acupuncture may treat DPD by restoring pathological alterations in brain neural activity. The findings will provide scientific evidence for acupuncture in the treatment of early PD with mild to moderate depression. Ethics and dissemination This clinical trial has been approved by the Medical Ethics Committee of the Beijing Hospital of Traditional Chinese Medicine (approval no. 2023BL02-013-01). This trial has been registered with the Chinese Clinical Trials Registry (registration no. ChiCTR2300069310). The results will be published in a peer-reviewed academic journal. Trial registration number： ChiCTR2300069310

    Keywords: Acupuncture, depression in Parkinson's disease, RCT - randomized controlled trial, fMRI, protocol

    Received: 03 Jul 2024; Accepted: 18 Sep 2024.

    Copyright: © 2024 Xiao, Ren, Yang, Wang, Li, Song, Yuan, Liu and Chen. 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:
    Yashuo Ren, Beijing University of Chinese Medicine, Beijing, China
    Haosen Yang, Beijing University of Chinese Medicine, Beijing, China
    Zixi Wang, Capital Medical University, Beijing, 100069, Beijing Municipality, China
    Yuguo Song, Beijing University of Chinese Medicine, Beijing, China
    Xiaojia Yuan, Beijing University of Chinese Medicine, Beijing, China
    Xiaopeng Liu, Beijing University of Chinese Medicine, Beijing, China
    Peng Chen, Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Beijing, 100010, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.