Background Selecting an optimal stimulation target is a persistent barrier to maximizing the efficacy of repetitive transcranial magnetic stimulation (rTMS) for subacute post-stroke aphasia. This trial evaluated an individualized, fNIRS-based targeting strategy derived from task-evoked activation during picture naming. Methods We conducted a double-blind, randomized, sham-controlled clinical trial. Patients with first-ever left-hemispheric stroke and subacute aphasia (1–6 months post-onset; 35–80 years) were recruited at Huashan Hospital (2021–2023) and randomized 1:1 to receive fNIRS-guided active rTMS or fNIRS-guided sham stimulation, in addition to 3 weeks of intensive speech-language therapy. Individual targets were defined as the fNIRS channel showing the strongest picture-naming task activation and were delivered under neuronavigation. Active stimulation used 10 Hz, 80% resting motor threshold, 2,000 pulses per session, for 15 sessions (3 weeks); sham used an identical schedule with a sham configuration. Primary/secondary outcomes included the Chinese Boston Naming Test (BNT), WAB-R indices, picture-naming behavioral performance, and task/resting-state fNIRS measures. Results Twenty-eight participants were enrolled and 27 completed the protocol (active rTMS: n = 14; sham: n = 13). Language performance improved over time in both groups; however, active rTMS produced significantly larger gains in confrontation naming on the BNT (Time × Group: F = 16.04, p 0.01) and higher picture-naming accuracy (Time × Group: F = 20.10, p 0.01), with an additional advantage on the WAB-R naming subscore (Time × Group: F = 4.44, p 0.05). Neurophysiologically, task-based fNIRS indicated increased activation in the left dorsolateral prefrontal cortex and left Broca’s area after active treatment, accompanied by strengthened resting-state connectivity between these regions; connectivity change was positively correlated with BNT improvement ( r = 0.6405, p 0.05). Conclusion fNIRS-guided rTMS protocol based on individualized, task-evoked activation mapping is a safe and effective approach for improving picture-naming performance in patients with subacute post-stroke aphasia. The intervention yields promising short-term therapeutic benefits and is associated with enhanced activation in the left dorsolateral prefrontal cortex and Broca’s area, as well as strengthened functional connectivity between these language-related regions. Clinical trial registration https://www.chictr.org.cn/showproj.html?proj=61768 , Unique identifier: ChiCTR2000038515.
Li et al. (Wed,) studied this question.
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