Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) in Attention-Deficit/Hyperactivity Disorder (Newrofeed)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
European Union H2020 SME Instrument
Information provided by (Responsible Party):
Mensia Technologies SA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit-Hyperactivity Disorder Device: Neurofeedback NFT Drug: Methylphenidate MPH Phase 1 Phase 2

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.

Other Names:
  • Neurofeedback training
  • ADHD@Home

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.
Other Names:
  • Methylphenidate long acting
  • Medikinet retard




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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%

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. Conners Continuous Performance Test 3rd Edition (Conners CPT 3) [ Time Frame: 2 times (Day 0, Day 90) ]
    Conners Continuous Performance Test 3rd Edition

  9. 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

  10. quantitative Electro-Encephalogram (qEEG) [ Time Frame: 3 times (Day 0, Day 60, Day 90) ]
    Quantitative electroencephalogram to assess EEG biomarkers, progress in brain modulation

  11. 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

  12. 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

  13. 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

  14. 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).


  15. Medical/surgical history [ Time Frame: 1 time (Day 0) ]
    Assessment especially related to the eligibility criteria

  16. 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.


  17. 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.


  18. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children or adolescents (male or female) aged 7-13 years
  • ADHD diagnosis positive with Kiddie-Sads
  • ADHD RS IV >6 for attention, with or without hyperactivity
  • Patient having already had corrective actions for ADHD (formal and informal educational support, psychoeducation, psychotherapy, occupational therapy remediation, at-school programs and remediations)
  • Signature of inform consent form by parent and child
  • Wireless internet connection at home

Exclusion Criteria:

  • ADHD hyperactive/Impulsive without inattention component
  • Established diagnosis of epilepsy or other neurological disorders
  • Severe and/or uncontrolled psychiatric disorder other than ADHD diagnosed with Kiddie-Sads such as autism, schizophrenia, severe generalized anxiety disorder, major depression or severe tics
  • Patient with comorbid disorder requiring psychoactive medication other than ADHD medication
  • Patient having already been treated with psycho-active drug (MPH and others) or EEG-NF for ADHD in the last 6 months, or more than 4 weeks more than 6 months ago
  • Unable to use the solution (tablet use and/or headset set-up and/or understanding instructions) according to the investigator
  • Absence of wireless internet connection at home
  • Medical disorder requiring systemic chronic medication with confounding psychoactive effects
  • IQ < 80 using the 3 subtest form of the WASI or the WISC
  • Plans to move requiring centre change during the next 6 months
  • Plans to start other ADHD treatment, including psychotherapy, cognitive behaviour training in the next 6 months
  • Patient with chronic medical illness such as seizure, cardiac disorders, untreated thyroid disease or glaucoma (contra-indication for treatment with MPH)
  • Significant suicidal risk based on clinical opinion
  • Patient with prescribed dietary interventions
  • Patient with a known hypersensitivity to one of the ingredients of the investigational products

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Michel Du Peloux, PhD 062-434-1061 ext +33 michel.du-peloux@mensiatech.com

Locations
Layout table for location information
Belgium
PSY Pluriel Centre europeen de psychologie medicale Recruiting
Bruxelles, Belgium, 1080
Contact: Laurent Victoor, MD/PhD    (0)2331-5665 ext +32    lvictoor@psypluriel.be   
Contact: Daniel Souery, MD/PhD    (0)2331-5665 ext +32    dsouery@psypluriel.be   
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    kristell.ackerman@erasme.ulb.ac.be   
Principal Investigator: Marie Delhaye, MD, PhD         
France
Centre Hospitalier Charles Perrens Recruiting
Bordeaux, France, 33076
Contact: Stephanie Bioulac, MD/PhD       stephanie.bioulac@chu-bordeaux.fr   
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         
Clinique LAUTREAMONT Recruiting
Lille, France, 59120
Contact: Frederic Kochman, MD/PhD    (0)82-610-9990 ext +33    f.kochman@orpea.net   
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       olivier.revol@chu-lyon.fr   
Principal Investigator: Olivier Revol, MD, PhD         
CHRU Montpellier Recruiting
Montpellier, France, 34000
Contact: Diane Purper-Ouakil, MD/PhD    (0)4 67 33 60 09 ext +33    d-purper_ouakil@chu.montpellier.fr   
Principal Investigator: Diane Purper-Ouakil, MD/PhD         
Germany
Universitätklinikum Erlangen Terminated
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    daniel.brandeis@zi-mannheim.de   
Contact: Tobias Banaschewski, MD/PhD         
Principal Investigator: Tobias Banaschewski, MD/PhD         
Spain
Puerta de Hierro Hospital - Department of Psychiatry Recruiting
Madrid, Spain, 28400
Contact: Hilario Blasco-Fontecilla, MD/PhD    (0)91 8503008 ext +34    hmblasco@yahoo.es   
Principal Investigator: Hilario Blasco-Fontecilla, MD/PhD         
Switzerland
Clinique des Grangettes Not yet recruiting
Genève, Switzerland, 1206
Contact: Caroline C Menache, MD/PhD    (0)22 305 0567 ext +41    caroline.menache@grangettes.ch   
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    brandeis@kjpd.uzh.ch   
Contact: Susanne Walitza, MD/MSc/Pr    (0)43 499 27 30 ext +41    susanne.walitza@puk.zh.ch   
Principal Investigator: Susanne Walitza, MD/MSc/Pr         
Sponsors and Collaborators
Mensia Technologies SA
European Union H2020 SME Instrument
Investigators
Layout table for investigator information
Study Director: Michel Du Peloux, PhD Mensia Technologies
Principal Investigator: Diane Purper-Ouakil, MD/PhD CHRU Montpellier
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mensia Technologies SA
ClinicalTrials.gov Identifier: NCT02778360    
Other Study ID Numbers: Newrofeed
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mensia Technologies SA:
Attention deficit
Neurofeedback
ADHD
Methylphenidate
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents