The application of cerebellar repetitive transcranial magnetic stimulation on aphasia after stroke: A randomized controlled trial protocol
TL;DR
The results of this trial will provide insights into whether cerebellar rTMS stimulation improves language function recovery in subacute phase PSA patients and strengthens the functional connection of the cerebro-cerebellar network, and enhances aphasia treatment outcomes by improving non-linguistic cognitive functions.
Abstract
Objectives Non-invasive brain stimulation has emerged as a safe, pain-free, and cost-effective method for post-stroke aphasia (PSA) rehabilitation. However, the ideal site for stimulation is yet to be determined. The cerebellum has demonstrated its role in language function though the application of repetitive transcranial magnetic stimulation (rTMS) targeting the cerebellum for PSA has not been well-documented. This study aims to assess the short- and long-term efficacy of rTMS on the right cerebellum in enhancing language recovery in patients with PSA in the subacute phase, and to explore its neuropsychological and neural network mechanisms as well. Methods Our study will recruit sixty-six PSA patients, who will be randomly divided into either a real or a sham rTMS group with equal distribution. The real rTMS group (n = 33) will receive rTMS treatment over the right cerebellar hemisphere along with speech-language therapy (SLT), while the sham group (n = 33) will receive sham stimulation and SLT. We will assess the outcomes at five intervals: before rTMS treatment, 2, 12, and 24 weeks, and 1-year post-treatment. The primary outcome in this research is the change in performance of the West Aphasia Battery from baseline to the final follow-up. Secondary outcomes include alterations in the structure, function, and perfusion neuroimaging data, as well as changes in non-verbal cognitive functions, measured using the Loewenstein Occupational Therapy Cognitive Assessment over time and between the groups. Any adverse event related to rTMS therapy will also be recorded. The results of this trial will provide insights into whether cerebellar rTMS stimulation (1) improves language function recovery in subacute phase PSA patients; (2) strengthens the functional connection of the cerebro-cerebellar network, and (3) enhances aphasia treatment outcomes by improving non-linguistic cognitive functions. We commenced patient recruitment for this trial in June 2026, and it is currently in progress. Registration This project was prospectively registered at the Chinese Clinical Trial Registry (ChiCTR2600125453).