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• This parallel-group study assessed the efficacy of Near-infrared spectroscopy (NIRS) based neurofeedback (NF) compared to atomoxetine(AT) on patients with ADHD. • Up to now, our trial is one of the few trials performed to evaluate its efficacy relative to medication. In this trial, NIRS-NF was an effective intervention for ADHD patients. • During the observation of 8 weeks, Patients in NIRS group showed significant efficacy in inattention, compared to AT group at week 3 and week 6. • At the same time, NIRS group had faster reaction time (RT) during Go/No-Go task and less errors during N-back than AT group. • The findings of this study reveal that NIRS-NF improves the behavioral performance more compared to AT, highlighting its potential role in treating patients with ADHD. The present study aimed to assess the efficacy of Near-infrared spectroscopy (NIRS) real-time neurofeedback (NF) vs. atomoxetine (AT) in children with attention deficit hyperactivity disorder (ADHD). A parallel-group study was conducted to enroll children with ADHD between 8 and 12 years of age. Participants were assigned into the NIRS group and AT group as their wish. Subjects in the NIRS group received 12 sessions of NF training within 6 weeks, and subjects in the AT group were given oral medication. Changes in Swanson, Nolan, and Pelham-V rating scales (SNAP-IV), and performance of Go/No-Go and N-back working memory tasks at week 3, 6 and 8 were evaluated. Forty-nine patients completed the study, including 18 ADHD in the NIRS group and 31 in the AT group. Total scores of SNAP-IV significantly decreased from baseline to week 3, week 6, and week 8 in both groups. Patients in the NIRS group showed significant lower scores on the inattention subscale of SNAP-IV at week 3 and week 6, compared to the AT group. NIRS group had a shorter reaction time during the Go/No-Go task at week 6 and fewer errors during 2-back than the AT group at week 3. The findings revealed that NIRS real-time NF is more efficacious relative to AT in improving behavioral performance, highlighting its potential role and advantages in treating patients with ADHD. [ABSTRACT FROM AUTHOR]