Cerebellar iTBS Combined With Emotional Stroop Task for Post-Stroke Depression: Randomized Controlled Trial Protocol From Kunming, China

Background Patients with stroke often experience both balance issues and poststroke depression (PSD), which can potentially influence each other. Despite incomplete knowledge of the specific mechanisms, the cerebellum plays a role in emotions and balance, which could be linked via the cerebellar-thalamus-cortical (CTC) pathway. Therefore, the cerebellum may serve as a common target for regulating emotional and balance functions post-stroke. Therefore, the aim of this study is to evaluate the efficacy of utilizing a combination of Stroop visual task and iTBS stimulation of the cerebellar vermis in enhancing emotions and balance function in stroke patients. Method 160 patients diagnosed with middle cerebral artery (MCA) infarction and post-stroke depression (PSD) will be randomly assigned to one of four groups: Group A (active iTBS of the cerebellar vermis with active Stroop training), Group B (sham iTBS with active Stroop training), Group C (active iTBS and sham Stroop training), and Group D (sham iTBS with sham Stroop training). The total intervention period will be two weeks. The primary outcome measures were evaluated using the Hamilton Depression Rating Scale (HAMD) and Berg Balance Scale at four different time points: baseline (T0), after five treatment sessions (T1), after ten treatment sessions (T2), and 4 weeks post-treatment (T3) during the follow-up period. The secondary outcomes will include EEG spectral analysis and MRI connectivity. Adverse effects will also be monitored to assess the safety of the intervention. Discussion By combining cerebellar iTBS with the emotional Stroop task, stroke patients may experience a simultaneous improvement in emotions and balance, with the enhancement being mediated through the same pathway as cerebellar TMS, specifically CTC. Trial registration: NCT direct link: https://www.chictr.org.cn/ ChiCTR2200058553. Registered in April 2022. The results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences (Protocol version 1.0–20240709).