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

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

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.

Keywords: Attention deficit hyperactivity disorder; Clinical trial; Methylphenidate; Neurofeedback.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart study design
Fig. 2
Fig. 2
Overview of the ADHD@Home Device

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