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

BMC Psychiatry
Stéphanie BioulacDaniel Brandeis

Abstract

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. 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 ...Continue Reading

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Citations

Jul 24, 2020·Clinical Psychopharmacology and Neuroscience : the Official Scientific Journal of the Korean College of Neuropsychopharmacology·Sheng-Hsiang YuWei-Lun Lin
Aug 29, 2020·Current Opinion in Psychiatry·Choon GuanDaniel S S Fung
Jun 25, 2021·Journal of Child Psychology and Psychiatry, and Allied Disciplines·Diane Purper-OuakilDaniel Brandeis

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Clinical Trials Mentioned

NCT02251743

Software Mentioned

Home
Improvers
SAS®
ADHD Home Follow - Up
ADHD
NEWROFEED
Mensia

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