Effects of Mobile Neurofeedback on Theta–Gamma Coupling and Clinical Outcomes in Children with ADHD: A Double-Blind, Sham-Controlled Randomized Clinical Trial

Jun Won Kim,1 Bung-Nyun Kim,2 Johanna Inhyang Kim,3 Chan-Mo Yang,4 Jaehyung Kwon5 1Department of Psychiatry, Daegu Catholic University School of Medicine, Daegu, Republic of Korea; 2Division of Child and Adolescent Psychiatry, Department of Psychiatry, Seoul National University Hospital, Seoul, Republic of Korea; 3Department of Psychiatry, Hanyang University College of Medicine, Seoul, Republic of Korea; 4Department of Psychiatry, Wonkwang University Hospital, Iksan, Republic of Korea; 5Affiliated Research Institute of 4N Inc., Daejeon, Republic of KoreaCorrespondence: Jun Won Kim, Department of Psychiatry, Daegu Catholic University School of Medicine, 33 Duryugongwon-ro 17-gil, Nam-gu, Daegu, Republic of Korea, Tel +82-53-650-4054, Fax +82-53-623-1694, Email [email protected]: This double-blinded randomized trial investigated the therapeutic effects of theta/beta mobile neurofeedback (MNF) in 8– 15-year-old ADHD and neurotypical children (randomized N = 139; analyzed N = 120).Methods: Participants were divided into three groups: ADHD Combination (MNF + Medication), ADHD MNF alone, and Neurotypical, and each group underwent 3 months of MNF intervention, either active or sham, the latter using randomly generated training results. Pre- and post-intervention electroencephalography tests were conducted, including an analysis of theta-gamma coupling (TGC), along with assessments of clinical variables.Results: Regarding clinical outcomes, MNF was not superior to sham in alleviating ADHD symptoms based on self-reports or in cognitive test performance, as indicated by limited changes in clinical variables. Before the intervention, the Neurotypical group exhibited higher TGC scores than the ADHD groups, reaffirming TGC as a neurophysiological marker for attention and working memory. Post-intervention, the ADHD Combination group with active MNF showed increased TGC in Fp2, F3, F4, F8, P4, O1, and O2, while the ADHD MNF alone group had mixed results. Notably, active MNF had no significant effect on TGC in the Neurotypical group, while sham MNF reduced TGC.Conclusion: MNF produced measurable neurophysiological modulation—reflected in enhanced TGC—when used as an adjunct to medication. Although clinical improvements were modest, these findings support TGC as a sensitive biomarker of MNF-induced brain regulation in ADHD.Keywords: ADHD, mobile neurofeedback, double-blind randomized controlled trial, theta-gamma coupling