A Phase 1/2 interventional study of Neurofeedback NFT and Methylphenidate MPH in Attention Deficit-Hyperactivity Disorder, sponsored by Mensia Technologies SA. Status unknown at 12 sites in 5 countries. Open to participants aged 7 Years to 13 Years. Per ClinicalTrials.gov, last updated 2017-04-05.
Sponsored by Mensia Technologies SA · Phase 1/2, Interventional, and Treatment
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's planned enrollment of 179 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →This is the only study on the registry with Mensia Technologies SA as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Neurofeedback Training based on real time electroencephalography (EEG) signal. The patient is trained to modulate his brain activity thanks to a tablet installed with serious game. Initiation/Discovery period during 21 days: initiation and discovery sessions Treatment period during 9 weeks: 36 training sessions at home
Device: Neurofeedback NFT
Methylphenidate long acting preparation. Open titration protocol during 21 days: 10 mg/day as a start until optimal dose is reached (maximum dose: 60 mg/day). Treatment period during 9 weeks: optimal dose with MPH LA 10 and 30 mg (dose range: 10 mg/day to 60 mg/day).
Drug: Methylphenidate MPH
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.
Also known as: Neurofeedback training, ADHD@Home
Drug prescribed with a first titration period until an optimal dose.
Also known as: Methylphenidate long acting, Medikinet retard
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)
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)
Plan to share: Undecided
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