Functional near-infrared spectroscopy-guided neurofeedback combined with art therapy and cognitive behavioral therapy for post-stroke depression: A randomized controlled trial

BACKGROUND: Post-stroke depression (PSD) is a common complication impairing recovery. This study aimed to compare standard cognitive behavioral therapy (CBT) with an enhanced version integrating functional near-infrared spectroscopy (fNIRS)-guided neurofeedback and art therapy (NF-AT+CBT) in patients with mild-to-moderate PSD. METHODS: In this multicenter, assessor-blinded randomized controlled trial, 50 patients were randomly assigned (1:1) to NF-AT+CBT or standard CBT for 12 weeks (two 45-60 min sessions/week). Primary outcome was change in Hamilton Depression Rating Scale-17 (HAMD-17) score; secondary outcomes included changes in serum IL-6 and TNF-α levels. RESULTS: The NF-AT+CBT group showed significantly greater HAMD-17 reduction at 12 weeks (-11.4 ± 2.5 vs. -8.6 ± 2.5, P < 0.001, Cohen's d = 1.1) and higher remission rate (80% vs. 40%, P = 0.009). Reductions in IL-6 and TNF-α were also significantly larger in the NF-AT+CBT group (both P < 0.001). Treatment adherence was excellent with no serious adverse events. CONCLUSION: Integrating fNIRS-guided neurofeedback and art tasks into CBT (NF-AT+CBT) produced greater improvement in depressive symptoms and inflammatory markers than standard CBT alone in mild-to-moderate PSD, suggesting a promising, feasible, and safe enhancement strategy. Larger trials with mechanistic assessments are warranted.