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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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6676623/ https://www.ncbi.nlm.nih.gov/pubmed/31370811 http://dx.doi.org/10.1186/s12888-019-2218-0 |
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author | Bioulac, Stéphanie Purper-Ouakil, Diane Ros, Tomas Blasco-Fontecilla, Hilario Prats, Marie Mayaud, Louis Brandeis, Daniel |
author_facet | Bioulac, Stéphanie Purper-Ouakil, Diane Ros, Tomas Blasco-Fontecilla, Hilario Prats, Marie Mayaud, Louis Brandeis, Daniel |
author_sort | Bioulac, Stéphanie |
collection | PubMed |
description | 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 |
format | Online Article Text |
id | pubmed-6676623 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-66766232019-08-06 Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD Bioulac, Stéphanie Purper-Ouakil, Diane Ros, Tomas Blasco-Fontecilla, Hilario Prats, Marie Mayaud, Louis Brandeis, Daniel BMC Psychiatry Study Protocol 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 BioMed Central 2019-08-01 /pmc/articles/PMC6676623/ /pubmed/31370811 http://dx.doi.org/10.1186/s12888-019-2218-0 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Bioulac, Stéphanie Purper-Ouakil, Diane Ros, Tomas Blasco-Fontecilla, Hilario Prats, Marie Mayaud, Louis Brandeis, Daniel Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD |
title | Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD |
title_full | Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD |
title_fullStr | Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD |
title_full_unstemmed | Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD |
title_short | Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD |
title_sort | personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with adhd |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6676623/ https://www.ncbi.nlm.nih.gov/pubmed/31370811 http://dx.doi.org/10.1186/s12888-019-2218-0 |
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