Journal article
Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD.
- Bioulac S CHU Pellegrin, Clinique du Sommeil, F-33076, Bordeaux, France. stephanie.bioulac@chu-bordeaux.fr.
- Purper-Ouakil D Unit of Child and Adolescent Psychiatry (MPEA1), CHU Montpellier-Saint Eloi Hospital, Montpellier, France.
- Ros T Department of Neurosciences, Laboratory for Neurology and Imaging of Cognition, University of Geneva, Geneva, Switzerland.
- Blasco-Fontecilla H Department of Psychiatry, Segovia de Arana Health Research Institute (IDIPHISA)-Puerta de Hierro University Hospital, Avenida Manuel de Falla s/n, Majadahonda, Madrid, Spain.
- Prats M Mensia Technologies, 130, rue de Lourmel, 75015, Paris, France.
- Mayaud L Mensia Technologies, 130, rue de Lourmel, 75015, Paris, France.
- Brandeis D University of Zurich and ETH Zurich, Neuroscience Center Zurich, Zurich, Switzerland.
- 2019-08-03
Published in:
- BMC psychiatry. - 2019
Attention deficit hyperactivity disorder
Clinical trial
Methylphenidate
Neurofeedback
Adolescent
Attention
Attention Deficit Disorder with Hyperactivity
Central Nervous System Stimulants
Child
Delayed-Action Preparations
Electroencephalography
Europe
Female
Humans
Male
Methylphenidate
Neurofeedback
Outcome Assessment, Health Care
Parents
Precision Medicine
Prospective Studies
Treatment Outcome
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s12888-019-2218-0
- PMID 31370811
- Persistent URL
- https://sonar.ch/global/documents/185328
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