Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) in Attention-Deficit/Hyperactivity Disorder (Newrofeed)
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|ClinicalTrials.gov Identifier: NCT02778360|
Recruitment Status : Unknown
Verified April 2017 by Mensia Technologies SA.
Recruitment status was: Recruiting
First Posted : May 19, 2016
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit-Hyperactivity Disorder||Device: Neurofeedback NFT Drug: Methylphenidate MPH||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||179 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
Experimental: Neurofeedback NFT
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
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.
Active Comparator: Methylphenidate MPH
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
Drug prescribed with a first titration period until an optimal dose.
- Change from Day 0 at Day 90 of the total score of the ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV) [ Time Frame: 3 times (Day 0, Day 60, Day 90) ]ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): total score assessed by the clinician
- ADHD RS IV Inattention and Hyperactivity Sub-Scores [ Time Frame: 3 times (Day 0, Day 60, Day 90) ]ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): Inattention and Hyperactivity sub-scores assessed by the clinician
- Clinical responders [ Time Frame: 1 time (Day 90) ]Clinical responders are subjects who will present a decrease of the total clinician ADHD RS score of more or equal to 25%
- Parents ADHD RS IV Total, Inattention and Hyperactivity Scores [ Time Frame: 3 times (Day 0, Day 60, Day 90) ]ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): Total, Inattention and Hyperactivity scores assessed by the parents
- Teacher ADHD RS IV Total, Inattention and Hyperactivity Scores [ Time Frame: 2 times (Day 0, Day 90) ]ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): Total, Inattention and Hyperactivity scores assessed by the teacher
- Clinical Global Impression (severity) (CGI-S) [ Time Frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90) ]Severity of the illness assessed by the clinician
- Clinical Global Impression (improvement) (CGI-I) [ Time Frame: 6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90) ]Improvement of the patient's condition assessed by the clinician
- Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: 2 times (Day 0, Day 90) ]Executive Function Tests by the Behavior Rating Inventory of Executive Function (BRIEF)
- Conners Continuous Performance Test 3rd Edition (Conners CPT 3) [ Time Frame: 2 times (Day 0, Day 90) ]Conners Continuous Performance Test 3rd Edition
- Strengths and Difficulties Questionnaire (SDQ) [ Time Frame: 2 times (Day 0, Day 90) ]Behaviour assessment by the parents and the teacher with the Strengths and Difficulties Questionnaire
- quantitative Electro-Encephalogram (qEEG) [ Time Frame: 3 times (Day 0, Day 60, Day 90) ]Quantitative electroencephalogram to assess EEG biomarkers, progress in brain modulation
- Columbia suicide severity rating scale (C-SSRS) [ Time Frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90) ]Columbia suicide severity rating scale
- Sleep Disturbance Scale for Children (SDSC) [ Time Frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90) ]Sleep Disturbance Scale for Children
- Pediatric adverse event rating scale (PAERS) [ Time Frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90) ]Pediatric adverse event rating scale
- Physical examination [ Time Frame: 1 time (Day 0) ]
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).
- Medical/surgical history [ Time Frame: 1 time (Day 0) ]Assessment especially related to the eligibility criteria
- Concomitant treatments collection [ Time Frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90) ]
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.
- Adverse events collection [ Time Frame: 6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90) ]
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.
- Child Health and Illness Profile, Child Edition (CHIP-CE) [ Time Frame: 2 times (Day 0, Day 90) ]Measure of the quality of life by the parents with the CHIP-CE parents report form
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778360
|Contact: Michel Du Peloux, PhD||062-434-1061 ext +firstname.lastname@example.org|
|PSY Pluriel Centre europeen de psychologie medicale||Recruiting|
|Bruxelles, Belgium, 1080|
|Contact: Laurent Victoor, MD/PhD (0)2331-5665 ext +32 email@example.com|
|Contact: Daniel Souery, MD/PhD (0)2331-5665 ext +32 firstname.lastname@example.org|
|Principal Investigator: Laurent Victoor, MD/PhD|
|Hôpital Erasme - Cliniques universitaires de Bruxelles||Not yet recruiting|
|Bruxelles, Belgium, B-1070|
|Contact: Marie Delhaye, MD, PhD (0)2 555 37 30 ext +32 Marie.Delhaye@erasme.ulb.ac.be|
|Contact: Kristell Ackerman, MD, PhD (0)2 555 35 96 ext +32 email@example.com|
|Principal Investigator: Marie Delhaye, MD, PhD|
|Centre Hospitalier Charles Perrens||Recruiting|
|Bordeaux, France, 33076|
|Contact: Stephanie Bioulac, MD/PhD firstname.lastname@example.org|
|Principal Investigator: Stephanie Bioulac, MD/PhD|
|CHRU de Lille - Hôpital Fontan - Service de psychiatrie de l'enfant et de l'adolescent||Recruiting|
|Lille, France, 59000|
|Contact: Renaud Jardri, Pr Renaud.JARDRI@chru-lille.fr|
|Contact: Aesa Parenti, MD, PhD (0)3 20 44 67 47 ext +33 AESA.PARENTI@chru-lille.fr|
|Principal Investigator: Renaud Jardri, Pr|
|Lille, France, 59120|
|Contact: Frederic Kochman, MD/PhD (0)82-610-9990 ext +33 email@example.com|
|Principal Investigator: Frederic Kochman, MD/PhD|
|Hospice Civil de Lyon - Hôpital Neurologique Service de Neuro-Psychiatrie de l'Enfant||Recruiting|
|Lyon, France, 59003|
|Contact: Olivier Revol, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Olivier Revol, MD, PhD|
|Montpellier, France, 34000|
|Contact: Diane Purper-Ouakil, MD/PhD (0)4 67 33 60 09 ext +33 email@example.com|
|Principal Investigator: Diane Purper-Ouakil, MD/PhD|
|Erlangen, Bayern, Germany, 91052|
|Medical faculty of Mannheim/Heidelberg university||Not yet recruiting|
|Mannheim, Germany, 68159|
|Contact: Daniel Brandeis, DSc/Pr (0)621 1703 4922 ext +49 firstname.lastname@example.org|
|Contact: Tobias Banaschewski, MD/PhD|
|Principal Investigator: Tobias Banaschewski, MD/PhD|
|Puerta de Hierro Hospital - Department of Psychiatry||Recruiting|
|Madrid, Spain, 28400|
|Contact: Hilario Blasco-Fontecilla, MD/PhD (0)91 8503008 ext +34 email@example.com|
|Principal Investigator: Hilario Blasco-Fontecilla, MD/PhD|
|Clinique des Grangettes||Not yet recruiting|
|Genève, Switzerland, 1206|
|Contact: Caroline C Menache, MD/PhD (0)22 305 0567 ext +41 firstname.lastname@example.org|
|Principal Investigator: Caroline Menache, MD/PhD|
|Psychiatric Hospital, University of Zürich||Not yet recruiting|
|Zürich, Switzerland, CH- 8032|
|Contact: Daniel Brandeis, MSc/Pr (0)43 499 2763 ext +41 email@example.com|
|Contact: Susanne Walitza, MD/MSc/Pr (0)43 499 27 30 ext +41 firstname.lastname@example.org|
|Principal Investigator: Susanne Walitza, MD/MSc/Pr|
|Study Director:||Michel Du Peloux, PhD||Mensia Technologies|
|Principal Investigator:||Diane Purper-Ouakil, MD/PhD||CHRU Montpellier|