Adjunctive PC6 magnetic stimulation with rTMS over left DLPFC for post-stroke cognitive impairment: a protocol for fNIRS-fMRI randomized controlled trial

BACKGROUND: Post‐stroke cognitive impairment (PSCI) is a common stroke complication, significantly reducing patients' quality of life and increasing caregiving burden. Repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (L‐DLPFC) improves cognition but with limited efficacy. Stimulation of Neiguan (PC6), a key acupoint in traditional Chinese medicine, modulates cognition‐related brain networks. OBJECTIVE: To compare cognitive improvement and brain network remodeling in PSCI patients who receive rTMS over the L‐DLPFC combined with (1) PC6 magnetic stimulation (MAG), (2) PC6 acupuncture (ACU), or (3) PC6 sham magnetic stimulation (SHM). METHODS: This three‐arm randomized controlled trial will enroll 105 patients with PSCI, randomly allocated 1:1:1 to the MAG (n = 35), ACU (n = 35), and SHM (n = 35) groups. Interventions will be administered 5 times/week for 3 weeks. All groups will receive high‐frequency rTMS over the L‐DLPFC (10 Hz, 80% rest motor threshold). The primary outcome is the Montreal Cognitive Assessment (MoCA) change from baseline to week 3. Secondary outcomes include the Mini‐Mental State Examination (MMSE), Modified Barthel Index (MBI), Hamilton Anxiety Rating Scale (HAMA), Hamilton Depression Rating Scale (HAMD), Pittsburgh Sleep Quality Index (PSQI), and adverse events. Functional magnetic resonance imaging (fMRI) and functional near‐infrared spectroscopy (fNIRS) data will be acquired at baseline and post 3‐week treatment. Clinical data will be analyzed via SPSS 26.0 using repeated measures analysis of variance (ANOVA) to compare intergroup changes in outcomes across time points. Neuroimaging data will be processed in MATLAB R2018a. Correlation analyses will assess associations between clinical scores and neuroimaging parameters. CONCLUSION: This study will provide the first randomized controlled evidence for acupoint magnetic stimulation in PSCI, demonstrating that adding MAG to L‐DLPFC rTMS confers additional cognitive benefits. Its mechanism in reshaping brain networks will be elucidated via fNIRS‐fMRI, which is expected to accelerate clinical translation of non‐pharmacological interventions. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/, identifier ChiCTR2400090768.