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BMC Psychiatry
Published in: BMC Psychiatry 1/2019

Open Access 01-12-2019 | Attention Deficit Hyperactivity Disorder | Study protocol

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

Authors: Stéphanie Bioulac, Diane Purper-Ouakil, Tomas Ros, Hilario Blasco-Fontecilla, Marie Prats, Louis Mayaud, Daniel Brandeis

Published in: BMC Psychiatry | Issue 1/2019

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Abstract

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
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Metadata
Title
Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD
Authors
Stéphanie Bioulac
Diane Purper-Ouakil
Tomas Ros
Hilario Blasco-Fontecilla
Marie Prats
Louis Mayaud
Daniel Brandeis
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2019
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-019-2218-0

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