Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13 Month Follow-up

OBJECTIVE: To determine whether theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback, NF) has a specific effect on attention-deficit/hyperactivity disorder (ADHD) beyond nonspecific benefit.

METHOD: In a 2-site double-blind randomized clinical trial, 144 children age 7-10 with rigorously diagnosed moderate/severe ADHD and theta/beta-ratio (TBR)>4.5 were randomized 3:2 to deliberate TBR downtraining vs. a control of equal duration, intensity, and appearance. Two early dropouts left 142 for modified intent-to-treat analysis. The control utilized pre-recorded EEGs with participant's artifacts superimposed. Treatment was programmed via internet by an off-site statistician-guided co-investigator. Fidelity was 98.7% by trainers/therapists, 93.2% by NF expert monitor. Primary outcome was parent- and teacher-rated inattention; analysis was mixed-effects regression. Because expense and effort of NF can be justified only by enduring benefit, follow-ups were integrated.

RESULTS: Blinding was excellent. While both groups showed significant improvement (p<0.001, d=1.5) in parent/teacher rated inattention from baseline to treatment-end and 13-month follow-up, NF was not significantly superior to the control condition at either time point on this primary outcome (d=0.01, p=0.965 at treatment end; d=0.23, p=.412 at 13-month follow-up). Responders (CGI-I=1-2) were 61% of NF and 54% of Controls (p=.36). Adverse events were distributed proportionally between treatments. 13-month follow-up found nonsignificant improvement from treatment end for NF (d=0.1), with mild deterioration for controls (d= -0.07). NF required significantly less medication at follow-up (p=.012).

CONCLUSION: This study does not support a specific effect of deliberate TBR NF at either treatment end or 13-month follow-up. Participants will be reassessed at 25-month follow-up.