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

Abstract

BACKGROUND\nNeurofeedback 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\xa0years. 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.\n\n\nMETHODS\nThe NF group (n\xa0=\xa0111) 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\xa0=\xa067) 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).\n\n\nTRIAL REGISTRATION\nUS National Institute of Health, ClinicalTrials.gov #NCT02778360.\n\n\nRESULTS\nOur 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\xa0=\xa00.89) in the NF and 46.9% (SMD\xa0=\xa02.03) in the control group. NF effects increased whereas those of methylphenidate were stable between intermediate and final visit.\n\n\nCONCLUSIONS\nBased on clinicians reports, the effects of at-home NF were inferior to those of methylphenidate as a stand-alone treatment.