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

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.