Neurofeedback for Attention-Deficit/Hyperactivity Disorder: 25-Month Follow-up of Double-Blind Randomized Controlled Trial

Abstract

To examine delayed effects of theta-beta ratio (TBR) neurofeedback (NF) for attention-deficit/hyperactivity disorder (ADHD) 25 months after baseline, ∼21 months after end of treatment. Children aged 7 to 10 years with rigorously diagnosed ADHD had been randomized to 38 sessions of TBR NF (n= 84) or control treatment (n= 58) of identical appearance, intensity/frequency, and duration, differing only in that reinforcement for controls was based on a pre-recorded electroencephalogram (EEG) of another child. Child, parent, and all site staff were blinded until after 25-month assessments, with only one-fourth able to guess the control treatment correctly. Baseline assessments were repeated off medication after 25 months. Of the 142 participants, 120 had 25-month follow-up (84.5% retention). Only 12 participants (6 controls) had NF after the study treatment, greatly retaining the randomization. The primary outcome, parent-rated inattention, was not significantly different between treatments despite large pre-post effect sizes (NF recipients, d= 1.63; controls, d= 1.42). Most secondary measures showed the same pattern. Response rates (Clinical Global Impression-Improvement≤2) were 58.6% of NF recipients and 66% of controls (not significant). Marginally more controls than NF recipients needed medication (57.1% vs 38.6%, p= .059); specifically, 7.1% of NF recipients and 4% of controls had reduced medication need, whereas 34.3% of NF recipients and 50% of controls needed more medication (p= 0.084). Most of the large within-group improvement from the NF treatment package reported by unblinded studies and replicated in this blinded study reflects nonspecific effects, not specific effects of deliberate down-training of EEG theta-beta power ratio. At 25-month follow-up, it appears comparable to the evidence-based Multimodal Treatment Study of ADHD (MTA) treatments, suggesting a psychotherapeutic/behavioral effect. Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD; http://clinicaltrials.gov/; NCT02251743. We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We worked to ensure that the study questionnaires were prepared in an inclusive way. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. We actively worked to promote sex and gender balance in our author group.