Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD.
Adolescent
Attention
Attention Deficit Disorder with Hyperactivity
/ therapy
Central Nervous System Stimulants
/ administration & dosage
Child
Delayed-Action Preparations
Electroencephalography
Europe
Female
Humans
Male
Methylphenidate
/ administration & dosage
Neurofeedback
/ methods
Outcome Assessment, Health Care
Parents
Precision Medicine
/ methods
Prospective Studies
Treatment Outcome
Attention deficit hyperactivity disorder
Clinical trial
Methylphenidate
Neurofeedback
Journal
BMC psychiatry
ISSN: 1471-244X
Titre abrégé: BMC Psychiatry
Pays: England
ID NLM: 100968559
Informations de publication
Date de publication:
01 08 2019
01 08 2019
Historique:
received:
17
09
2018
accepted:
23
07
2019
entrez:
3
8
2019
pubmed:
3
8
2019
medline:
25
4
2020
Statut:
epublish
Résumé
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 an SMR or a Theta/Beta training protocol according to their baselineTheta/Beta Ratio obtained from the qEEG. 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. NCT02778360 . Date registration (retrospectively registered): 5-12-2016. Registered May 19, 2016.
Sections du résumé
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.
Identifiants
pubmed: 31370811
doi: 10.1186/s12888-019-2218-0
pii: 10.1186/s12888-019-2218-0
pmc: PMC6676623
doi:
Substances chimiques
Central Nervous System Stimulants
0
Delayed-Action Preparations
0
Methylphenidate
207ZZ9QZ49
Banques de données
ClinicalTrials.gov
['NCT02778360']
Types de publication
Equivalence Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
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