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

• Published in: BMC psychiatry Vol. 19; no. 1; pp. 237 - 13
• Main Authors: Bioulac, Stéphanie, Purper-Ouakil, Diane, Ros, Tomas, Blasco-Fontecilla, Hilario, Prats, Marie, Mayaud, Louis, Brandeis, Daniel
• Format: Journal Article
• Language: English
• Published: London BioMed Central 01.08.2019; Springer Nature B.V; BMC
• Subjects: Adolescent; adolescent and developmental psychiatry; Attention; Attention Deficit Disorder with Hyperactivity - therapy; Attention deficit hyperactivity disorder; Autism; Behavior; Biofeedback; Central Nervous System Stimulants - administration & dosage; Child; Child & adolescent psychiatry; Children; Clinical trial; Cognition & reasoning; Cognitive science; Delayed-Action Preparations; EEG; Electroencephalography; Europe; Executive function; Feedback; Female; Human health and pathology; Humans; Hyperactivity; Impulsivity; Life Sciences; Male; Medical innovations; Medicine; Medicine & Public Health; Mental disorders; Methylphenidate; Methylphenidate - administration & dosage; Neurofeedback; Neurofeedback - methods; Outcome Assessment, Health Care; Parents; Parents & parenting; Patients; Pediatrics; Precision Medicine - methods; Prospective Studies; Psychiatrics and mental health; Psychiatry; Psychotherapy; Schizophrenia; Stimulants; Study Protocol; Teenagers; Titration; Treatment Outcome; Europe; Clinical trial; Attention deficit hyperactivity disorder; Neurofeedback; Methylphenidate
• ISSN: 1471-244X; 1471-244X
• DOI: 10.1186/s12888-019-2218-0

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