STUDY PROTOCOL article
Front. Neurol.
Sec. Neurorehabilitation
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1576620
This article is part of the Research TopicBrain stimulation for cognitive impairments in psychiatric and neurodegenerative disordersView all articles
The Efficacy and Neuroplasticity of Tuina Combined with Repetitive Transcranial Magnetic Stimulation in the Treatment of Post-Stroke Depression: Study protocol for a single-center, randomized, controlled trial
Provisionally accepted
- Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
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Post-stroke depression (PSD), characterized by low mood and low interest, is the most common complication after stroke. The limitations of PSD drug therapy often require multidisciplinary combination therapy in clinical practice. Tuina therapy and repetitive transcranial magnetic stimulation (rTMS) have shown potential in modulating neural plasticity and improving depressive symptoms. However, the combined efficacy of these non-pharmacological therapies on PSD and their underlying mechanisms remain underexplored. This study aims to investigate the clinical effectiveness of massage combined with rTMS in treating PSD and explore its impact on brain functional networks and neuroendocrine mechanisms.This study is a non-inferiority randomized controlled trial (RCT). One hundred and twenty-eight participants with PSD will be randomly assigned (1:1) to the intervention group (Tuina + rTMS treatment) and the control group (cognitive behavior treatment). The primary efficacy outcome is the change from baseline to week 2 in Hamilton Depression Rating Scale (HAMD) and Functional Magnetic Resonance Imaging (fMRI). Secondary efficacy outcomes include other assessments of the Mini-Mental State Examination (MMSE), The modified Barthel index (MBI), The National Institutes of Health Stroke Scale(NIHSS), inflammatory factor (IL-6、IL-17、TNF-α、IFN-γ、IL-4、IL-10), and Functional near-infrared spectroscopy (fNIRS). Efficacy and scale assessments will be conducted at 1 month and 3 months after the completion of treatment.This trial will provide reliable evidence on the efficacy of Tuina combined with rTMS in treating PSD and explore its impact on brain functional networks and neuroendocrine mechanisms.Tr ial r egistr ationThe trial was registered at Chinese Clinical Trial Registry https//www.chictr.org.cn/bin/ project/edit?pid=232672(RegistrationNo.: ChiCTR2400085310). Date: 2024-06-05.
Keywords: Tuina, repetitive transcranial magnetic stimulation, post-stroke depression, functional magnetic resonance imaging, study protocol
Received: 17 Feb 2025; Accepted: 09 Jul 2025.
Copyright: © 2025 Ma, Gao, Chen, Hu, Gao, Gu, He, Jin, Tao and Fang. 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:
Jiming Tao, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Min Fang, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
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