fNIRS-Guided neuronavigated rTMS augments naming recovery in subacute post-stroke aphasia: a double-blind randomized controlled trial

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: < 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.