Background
Neurofeedback (NF) is a nonpharmacological approach for ADHD, but standard protocols often overlook individual EEG variability, potentially limiting efficacy. We report the first double-blind randomized controlled trial of a session-adaptive individualized upper-alpha NF protocol in children with ADHD, based on individualized 1/f + alpha model.
Methods
Forty-eight children (6–12 years) diagnosed with ADHD were randomized to individualized upper-alpha NF (n = 26) or sham feedback (n = 22). Participants completed eight 1-h sessions over four weeks. The primary outcome was parent-rated ADHD symptoms on the SWAN scale, measured at baseline, post-treatment, and follow-up. Secondary outcomes included PedsQL, CBCL, SDQ, and neuropsychological tests. Intention-to-treat linear mixed-effects models assessed Time × Condition interactions; within-group changes were evaluated via paired t-tests. EEG learning was defined as the change in each session’s upper-alpha/theta-to-lower-alpha ratio.
Results
Blinding was preserved (Bang’s Index: caregivers = 0.13; staff = 0.21). In the NF group, 21/26 children (80.7%) achieved ‘learner’ status versus 36.4% in sham. Both groups showed significant reductions in ADHD symptoms post-treatment (SWAN Total: NF, d = −0.879, p < .001; sham, d = −1.261, p < .001), with no between-group difference (d = −0.062, p = .881). At six months, NF maintained improvements in ADHD symptoms (SWAN Total: d = −0.713, p = .006), without superiority over sham (d = 0.221, p = .633). Neuropsychological testing revealed NF-specific gains in Purdue Pegboard non-preferred hand (d = 1.093, FDR q = .042) and faster CPT-3 reaction time (d = −1.210, FDR q = .025).
Conclusions
Personalized upper-alpha NF produced higher EEG learning and selective motor-speed improvements but did not outperform sham in reducing parent-rated ADHD symptoms. Eight sessions sufficed for robust EEG modulation, yet non-specific training effects likely drove clinical gains, indicating NF alone may not be an adequate ADHD treatment.