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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
179
The ADHD@Home Device is composed of a software for NF Training deployed on a Windows tablet, and connected to an EEG headset and an amplifier. The training is personalized according to patient's characteristics.
Drug prescribed with a first titration period until an optimal dose.
PSY Pluriel Centre europeen de psychologie medicale
Brussels, Belgium
RECRUITINGHôpital Erasme - Cliniques universitaires de Bruxelles
Brussels, Belgium
Change from Day 0 at Day 90 of the total score of the ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV)
ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): total score assessed by the clinician
Time frame: 3 times (Day 0, Day 60, Day 90)
ADHD RS IV Inattention and Hyperactivity Sub-Scores
ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): Inattention and Hyperactivity sub-scores assessed by the clinician
Time frame: 3 times (Day 0, Day 60, Day 90)
Clinical responders
Clinical responders are subjects who will present a decrease of the total clinician ADHD RS score of more or equal to 25%
Time frame: 1 time (Day 90)
Parents ADHD RS IV Total, Inattention and Hyperactivity Scores
ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): Total, Inattention and Hyperactivity scores assessed by the parents
Time frame: 3 times (Day 0, Day 60, Day 90)
Teacher ADHD RS IV Total, Inattention and Hyperactivity Scores
ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): Total, Inattention and Hyperactivity scores assessed by the teacher
Time frame: 2 times (Day 0, Day 90)
Clinical Global Impression (severity) (CGI-S)
Severity of the illness assessed by the clinician
Time frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Clinical Global Impression (improvement) (CGI-I)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centre Hospitalier Charles Perrens
Bordeaux, France
RECRUITINGCHRU de Lille - Hôpital Fontan - Service de psychiatrie de l'enfant et de l'adolescent
Lille, France
RECRUITINGClinique LAUTREAMONT
Lille, France
RECRUITINGHospice Civil de Lyon - Hôpital Neurologique Service de Neuro-Psychiatrie de l'Enfant
Lyon, France
RECRUITINGCHRU Montpellier
Montpellier, France
RECRUITINGUniversitätklinikum Erlangen
Erlangen, Bavaria, Germany
TERMINATEDMedical faculty of Mannheim/Heidelberg university
Mannheim, Germany
NOT_YET_RECRUITINGPuerta de Hierro Hospital - Department of Psychiatry
Madrid, Spain
RECRUITING...and 2 more locations
Improvement of the patient's condition assessed by the clinician
Time frame: 6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Behavior Rating Inventory of Executive Function (BRIEF)
Executive Function Tests by the Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: 2 times (Day 0, Day 90)
Conners Continuous Performance Test 3rd Edition (Conners CPT 3)
Conners Continuous Performance Test 3rd Edition
Time frame: 2 times (Day 0, Day 90)
Strengths and Difficulties Questionnaire (SDQ)
Behaviour assessment by the parents and the teacher with the Strengths and Difficulties Questionnaire
Time frame: 2 times (Day 0, Day 90)
quantitative Electro-Encephalogram (qEEG)
Quantitative electroencephalogram to assess EEG biomarkers, progress in brain modulation
Time frame: 3 times (Day 0, Day 60, Day 90)
Columbia suicide severity rating scale (C-SSRS)
Columbia suicide severity rating scale
Time frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Sleep Disturbance Scale for Children (SDSC)
Sleep Disturbance Scale for Children
Time frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Pediatric adverse event rating scale (PAERS)
Pediatric adverse event rating scale
Time frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Physical examination
Physical examination will include assessments of height, weight, cardiac frequency, cardiac exam and blood pressure. Investigator will question the parents about the cardiac history of the family and on individual risk factors. If a risk factor is detected, the patient will be addressed to a cardiologist for an electrocardiogram (ECG).
Time frame: 1 time (Day 0)
Medical/surgical history
Assessment especially related to the eligibility criteria
Time frame: 1 time (Day 0)
Concomitant treatments collection
All the treatments taken during the participation will be collected (trade name, indication, dose, onset/end dates). The use of concomitant medications will be summarized by therapeutic class.
Time frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Adverse events collection
All the adverse events occurred during the participation will be collected until resolution or stabilization (description/symptoms, onset/end dates, frequency, intensity, evolution, causality to treatment attributed, seriousness). All adverse events will be described in each arm. A comparison will be done, especially concerning number and percentage of patients who experienced at least one adverse event (on the whole and by system/organ), at least one adverse event leading to discontinue the treatment, and at least one serious adverse event.
Time frame: 6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Child Health and Illness Profile, Child Edition (CHIP-CE)
Measure of the quality of life by the parents with the CHIP-CE parents report form
Time frame: 2 times (Day 0, Day 90)