# 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

## TL;DR

This study will test if combining Tuina massage and rTMS is effective for treating post-stroke depression and how it affects brain function and hormones.

## Contribution

The study introduces a novel combination of Tuina and rTMS for post-stroke depression and explores its effects on brain networks and neuroendocrine mechanisms.

## Key findings

- The trial will assess the efficacy of Tuina + rTMS on depression symptoms using HAMD and fMRI.
- It will examine the impact on brain function and neuroendocrine markers like IL-6 and TNF-α.
- Results will be evaluated at 1 and 3 months post-treatment.

## Abstract

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.