Effects of intermittent theta-burst stimulation (iTBS) on post-stroke depression (PSD): A study protocol for a single-center randomized controlled trial

IF 1.5 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2026-02-01 Epub Date: 2026-01-31 DOI:10.1016/j.conctc.2026.101599

Yanbiao Zhong , Meng Ren , Wenjing Wang , Juanlian He , Yonghui Zhong , Jingjing Xu , YuanLi Li , Sicong Zhang , Chunlei Shan

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引用次数: 0

Abstract

Introduction

Intermittent theta-burst stimulation (iTBS) is a specific type of repetitive transcranial magnetic stimulation (rTMS) paradigm with long-lasting effects and a short session duration. Although randomized controlled trials have suggested that iTBS is effective for treating depression, few studies have investigated the effects of iTBS in treating post-stroke depression (PSD). The purpose of the present study is to investigate whether iTBS can be used to treat PSD. We will also investigate the corresponding mechanisms of iTBS via functional magnetic resonance imaging (fMRI).

Methods and analysis

We will recruit 36 PSD patients for this single-center, randomized, sham-controlled trial. Subjects will be randomly divided into the following two groups according to a 1:1 ratio: the active iTBS group and the sham iTBS group. The data will be collected at 0 and 10 d after the commencement of treatment. The primary outcome will be comprised of scores on the 17-item Hamilton Depression Rating Scale. The secondary outcomes will consist of MRI results and the results of neuropsychological tests, including the Brief 16-item Quick Inventory of Depressive Symptomatology Self-Report, Hamilton Anxiety Scale, Snaith-Hamilton Pleasure Scale for clinician administration, and Young Mania Rating Scale.

Ethics and dissemination

Ethics approval has been granted by the Ethics Committee of Yueyang Integrative Medicine Hospital, an affiliate of Shanghai University of Traditional Chinese Medicine (Shanghai, China; Grant No. 2019-108). Written informed consent will be obtained from each participant before any procedures are performed. The findings will be published in peer-reviewed journals and presented at academic conferences.

Trial registration number

ChiCRT1900027686.

Abstract Image

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间歇性猝发刺激（iTBS）对脑卒中后抑郁（PSD）的影响：一项单中心随机对照试验的研究方案

简介：间歇性脉冲刺激（iTBS）是一种特殊类型的重复性经颅磁刺激（rTMS）模式，具有持久的效果和短的持续时间。虽然随机对照试验表明iTBS对治疗抑郁症有效，但很少有研究调查iTBS治疗脑卒中后抑郁症（PSD）的效果。本研究的目的是探讨iTBS是否可以用于治疗PSD。我们还将通过功能磁共振成像（fMRI）研究iTBS的相应机制。方法与分析：我们将招募36名PSD患者进行这项单中心、随机、假对照试验。受试者将按照1:1的比例随机分为以下两组：活性iTBS组和假iTBS组。数据将于治疗开始后0和10 d采集。主要结果将由17项汉密尔顿抑郁评定量表的分数组成。次要结果将包括MRI结果和神经心理测试结果，包括简短的16项抑郁症状自我报告快速清单，汉密尔顿焦虑量表，Snaith-Hamilton愉悦量表用于临床给药，以及Young躁狂评定量表。伦理与传播：已获得上海中医药大学附属岳阳中西医结合医院伦理委员会伦理批准（中国上海，批准号2019-108）。在进行任何程序之前，将获得每位参与者的书面知情同意。研究结果将发表在同行评议的期刊上，并在学术会议上发表。试验注册号：ChiCRT1900027686。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.