RESUMO
BACKGROUND: Aphasia affects approximately one-third of stroke patients and yet its rehabilitation outcomes are often unsatisfactory. More effective strategies are needed to promote recovery. OBJECTIVE: We aimed to examine the efficacy and safety of the theta-burst stimulation (TBS) on the language area in the superior frontal gyrus (SFG) localized by personalized functional imaging, in facilitating post-stroke aphasia recovery. METHODS: This randomized sham-controlled trial uses a parallel design (intermittent TBS [iTBS] in ipsilesional hemisphere vs. continuous TBS [cTBS] in contralesional hemisphere vs. sham group). Participants had aphasia symptoms resulting from their first stroke in the left hemisphere at least one month prior. Participants received three-week speech-language therapy coupled with either active or sham stimulation applied to the left or right SFG. The primary outcome was the change in Western Aphasia Battery-Revised (WAB-R) aphasia quotient after the three-week treatment. The secondary outcome was WAB-R aphasia quotient improvement after one week of treatment. RESULTS: Ninety-seven patients were screened between January 2021 and January 2022, 45 of whom were randomized and 44 received intervention (15 in each active group, 14 in sham). Both iTBS (estimated difference = 14.75, p < 0.001) and cTBS (estimated difference = 13.43, p < 0.001) groups showed significantly greater improvement than sham stimulation after the 3-week intervention and immediately after one week of treatment (p's < 0.001). The adverse events observed were similar across groups. A seizure was recorded three days after the termination of the treatment in the iTBS group. CONCLUSION: The stimulation showed high efficacy and SFG is a promising stimulation target for post-stroke language recovery.