Attention Deficit-Hyperactivity Disorder Clinical Trial
Official title:
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
The main objective of the study is to demonstrate the non-inferiority of the personalized Neurofeedback Training device versus Methylphenidate in the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder.
The main objective of the present study is to demonstrate the non-inferiority of the
personalized Neurofeedback Training device ADHD@Home versus Methylphenidate in the treatment
of children and adolescents with Attention-Deficit/Hyperactivity Disorder.
Furthermore, it is aimed to learn more about the mechanisms underlying NeuroFeedback.
The study is prospective, multicentric (9 centres), randomised, reference drug-controlled.
ADHD@Home is a neuromarkerTM-based personalized medicine device to treat children suffering
from Attention Deficit Hyperactivity Disorders (ADHD) with Neurofeedback Training (NFT)
based on real time electroencephalography (EEG) signal.
Neurofeedback Training is based on direct training of brain function, by which the brain
learns to function more efficiently. For each session of the ADHD@Home solution, the child
is trained to modulate his brain activity in a serious game, which is a real-time metaphor
of the EEG biomarker that needs to be 'normalized', following a typical operant learning
process.
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