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

被引：20

作者：

Bioulac, Stephanie ^{[1
,2
,3
]}

Purper-Ouakil, Diane ^{[4
]}

Ross, Tomas ^{[5
]}

Blasco-Fontecilla, Hilario ^{[6
,7
]}

Prats, Marie ^{[8
]}

Mayaud, Louis ^{[8
]}

Brandeis, Daniel ^{[9
,10
,11
]}

机构：

[1] CHU Pellegrin, Clin Sommeil, F-33076 Bordeaux, France

[2] Univ Bordeaux, Sommeil Addict & Neuropsychiat, USR 3413, F-33000 Bordeaux, France

[3] CNRS, SANPSY, USR 3413, F-33000 Bordeaux, France

[4] CHU Montpellier St Eloi Hosp, Unit Child & Adolescent Psychiat MPEA1, Montpellier, France

[5] Univ Geneva, Dept Neurosci, Lab Neurol & Imaging Cognit, Geneva, Switzerland

[6] Puerta de Hierro Univ Hosp, Segovia de Arana Hlth Res Inst IDIPHISA, Dept Psychiat, Ave Manuel Falla S-N, Madrid, Spain

[7] Univ Autonoma Madrid, Madrid, Spain

[8] Mensia Technol, 130 Rue Lourmel, F-75015 Paris, France

[9] Univ Zurich, Zurich, Switzerland

[10] Swiss Fed Inst Technol, Neurosci Ctr Zurich, Zurich, Switzerland

[11] Heidelberg Univ, Cent Inst Mental Hlth, Dept Child & Adolescent Psychiat & Psychotherapy, Med Fac Mannheim, Mannheim, Germany

来源：

BMC PSYCHIATRY | 2019年 / 19卷 / 1期

关键词：

Attention deficit hyperactivity disorder; Neurofeedback; Methylphenidate; Clinical trial; ATTENTION-DEFICIT/HYPERACTIVITY DISORDER; DEFICIT HYPERACTIVITY DISORDER; DIFFICULTIES QUESTIONNAIRE; VALIDITY; SCALE; EEG; BRAIN; CONSISTENCY; ANNOTATION; VALIDATION;

D O I：

10.1186/s12888-019-2218-0

中图分类号：

R749 [精神病学];

学科分类号：

100205 ;

摘要：

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 13years 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.DiscussionThis is the first non-inferiority study between a personalized NF device and pharmacological treatment. Innovative aspects of Mensia Koala (TM) 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

引用

页数：13

共 56 条

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