Editorial: Neurofeedback in Attention-Deficit/Hyperactivity Disorder: Still No Evidence of Specific Effects.

The Neurofeedback Collaborative Group presents the results from a 25-month follow-up, randomized controlled study of theta/beta ratio (TBR) down-training electroencephalography neurofeedback (EEG-NF).1 NF is a computer-based training with real-time brain activity- contingent feedback in the form of a game with audio-visual rewards. These rewards aim to reinforce learning of neural activity patterns related to attention or behavioral control. The down-training of the TBR is considered a standard protocol of EEG-NF. The same group has previously published their findings about effects at the end of treatment and 13-month follow-up without evidence of specific NF effects on the primary outcome, a composite score of parent and teacher ratings of inattention. However, participants in the NF group had less need for medication than those in the control group.2 This randomized controlled trial has several strengths, including a sophisticated "sham NF," excellent blinding of parents and investigators, fidelity procedures, and the use of a standard protocol in a population with elevated TBR. The control group was designed to overcome some of the downsides of previous sham-NF protocols by matching the patient's artifacts on the control electroencephalogram. In their current publication, the Neurofeedback Collaborative Group focuses on the possibility of delayed therapeutic NF effects that are thought to be due to the progressive learning of brain activity control.3 These putative delayed effects and lasting benefits are essential issues in determining the utility of NF in ADHD, because previous studies with blinded or probably-blinded assessments showed no short-term differences between NF and control conditions.4 Results confirm the pre-post effect sizes of previous studies, without significant group differences at the 25-month assessment, indicated that there are no specific effects of the NF training paradigm. This is in line with another recent randomized sham-controlled trial with functional magnetic resonance imaging-NF showing no group differences either on the clinical primary outcome or on cognitive functioning in children with attention-deficit/hyperactivity disorder (ADHD).5.

Personalized at-home neurofeedback compared to long-acting methylphenidate in children with ADHD: NEWROFEED, a European randomized noninferiority trial.

BACKGROUND: Neurofeedback is considered a promising intervention for the treatment of attention-deficit hyperactivity disorder (ADHD). NEWROFEED is a prospective, multicentre, randomized (3:2), reference drug-controlled trial in children with ADHD aged between 7 and 13 years. The main objective of NEWROFEED was to demonstrate the noninferiority of personalized at-home neurofeedback (NF) training versus methylphenidate in the treatment of children with ADHD. METHODS: The NF group (n = 111) underwent eight visits and two treatment phases of 16 to 20 at-home sessions with down-training of the theta/beta ratio (TBR) for children with high TBR and enhancing the sensorimotor rhythm (SMR) for the others. The control group (n = 67) received optimally titrated long-acting methylphenidate. The primary endpoint was the change between baseline and endpoint in the Clinician ADHD-RS-IV total score in the per-protocol population (90 NF/59 controls). TRIAL REGISTRATION: US National Institute of Health, ClinicalTrials.gov #NCT02778360. RESULTS: Our study failed to demonstrate noninferiority of NF versus methylphenidate (mean between-group difference 8.09 90% CI [8.09; 10.56]). However, both treatment groups showed significant pre-post improvements in core ADHD symptoms and in a broader range of problems. Reduction in the Clinician ADHD-RS-IV total score between baseline and final visit (D90) was 26.7% (SMD = 0.89) in the NF and 46.9% (SMD = 2.03) in the control group. NF effects increased whereas those of methylphenidate were stable between intermediate and final visit. CONCLUSIONS: Based on clinicians' reports, the effects of at-home NF were inferior to those of methylphenidate as a stand-alone treatment.

Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD.

BACKGROUND: Neurofeedback (NF) has gained increasing interest among non-pharmacological treatments for Attention Deficit Hyperactivity Disorder (ADHD). NF training aims to enhance self-regulation of brain activities. The goal of the NEWROFEED study is to assess the efficacy of a new personalized NF training device, using two different protocols according to each child's electroencephalographic pattern, and designed for use at home. This study is a non-inferiority trial comparing NF to methylphenidate. METHODS: The study is a prospective, multicentre, randomized, reference drug-controlled trial. One hundred seventy-nine children with ADHD, aged 7 to 13 years will be recruited in 13 clinical centres from 5 European countries. Subjects will be randomized to two groups: NF group (Neurofeedback Training Group) and MPH group (Methylphenidate group). Outcome measures include clinicians, parents and teachers' assessments, attention measures and quantitative EEG (qEEG). Patients undergo eight visits over a three-month period: pre-inclusion visit, inclusion visit, 4 "discovery" (NF group) or titration visits (MPH group), an intermediate and a final visit. Patients will be randomized to either the MPH or NF group. Children in the NF group will undergo either an SMR or a Theta/Beta training protocol according to their baselineTheta/Beta Ratio obtained from the qEEG. DISCUSSION: This is the first non-inferiority study between a personalized NF device and pharmacological treatment. Innovative aspects of Mensia Koala™ include the personalization of the training protocol according to initial qEEG characteristics (SMR or Theta/Beta training protocols) and an improved accessibility of NF due to the opportunity to train at home with monitoring by the clinician through a dedicated web portal. TRIAL REGISTRATION: NCT02778360 . Date registration (retrospectively registered): 5-12-2016. Registered May 19, 2016.