Evidence map›Paper›PMID 31370811›Full record

ArticleBMC psychiatry2019

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

Registry-linked trialAbstract readEquivalence Trial
In one paragraph

Article in BMC psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02778360 (Effectiveness of a Personalized Neurofeedback Training Device), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02778360 phase1 / phase2unknown statusnot on this map

Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) as Compared With Methylphenidate in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Multicentre Randomized Clinical Study

TypeinterventionalSponsorMensia Technologies SARan2016 to 2017Enrolled179ConditionsAttention Deficit-Hyperactivity DisorderArmsNeurofeedback NFT, Methylphenidate MPH
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. A Neurofeedback Protocol for Executive Function to Reduce Depression and Rumination: A Controlled Study.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2020
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Stéphanie BioulacCHU Pellegrin, Clinique du Sommeil, F-33076, Bordeaux, France. stephanie.bioulac@chu-bordeaux.fr.
Diane Purper-OuakilUnit of Child and Adolescent Psychiatry (MPEA1), CHU Montpellier-Saint Eloi Hospital, Montpellier, France.
Tomas RosDepartment of Neurosciences, Laboratory for Neurology and Imaging of Cognition, University of Geneva, Geneva, Switzerland.
Hilario Blasco-FontecillaDepartment of Psychiatry, Segovia de Arana Health Research Institute (IDIPHISA)-Puerta de Hierro University Hospital, Avenida Manuel de Falla s/n, Majadahonda, Madrid, Spain.
Marie PratsMensia Technologies, 130, rue de Lourmel, 75015, Paris, France.
Louis MayaudMensia Technologies, 130, rue de Lourmel, 75015, Paris, France.
Daniel BrandeisUniversity of Zurich and ETH Zurich, Neuroscience Center Zurich, Zurich, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeurofeedback (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.

methodsThe 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 registrationNCT02778360 . Date registration (retrospectively registered): 5-12-2016. Registered May 19, 2016.

Indexed as

AdolescentAttentionAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsChildDelayed-Action PreparationsElectroencephalographyEuropeFemaleHumansMaleMethylphenidateNeurofeedbackOutcome Assessment, Health CareParentsPrecision MedicineCentral Nervous System StimulantsDelayed-Action PreparationsMethylphenidateAttention deficit hyperactivity disorderClinical trialMethylphenidateNeurofeedback

Identifiers

PMID31370811
PMCPMC6676623

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.