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.
In a parallel-group double-blind RCT, 142 children 7 to 10 years of age with categorically (structured interview) and dimensionally (T score of 65 or more on a normed scale of ADHD symptoms) diagnosed ADHD were randomized to a standard NF protocol (n = 84) vs a control treatment (n = 58) of identical appearance, intensity, and duration for 38 sessions at 3 times per week. Major assessments were performed at baseline, mid-treatment, treatment end, and at 6, 13, and 25 months after baseline. The
At 25 months, about 21 months after the end of treatment, we retained 120 of the 142 randomized participants (Figure 1). Table 1 shows the baseline characteristics of those 120 children. Only 12 (6 controls and 6 NF) had any NF during the follow-up period, which maintained the original randomization to a great extent (∼90%).
The baseline, treatment-end, and 25-month outcomes are shown in Table 2 and Figure 2. Improvement from baseline to 25 months in the primary outcome for 25 months
This was the first large well-blinded randomized trial of NF for ADHD. This 25-month follow-up of the 3- to 4-month treatment was designed into the trial from the beginning to match the 36-month MTA follow-up after the MTA 14-month treatment. In contrast to most drug study follow-ups, in which the control group is “contaminated” by post-trial medication, only 10% of this sample received NF during follow-up (equally divided between original treatment groups), and the average number of treatments
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