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Attention Deficit-Hyperactivity DisorderPhase 1/2NewrofeedNCT02778360

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

A Phase 1/2 study testing Neurofeedback NFT and Methylphenidate MPH in people with Attention Deficit-Hyperactivity Disorder, run by Mensia Technologies SA at 12 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 13 years
Conditions the study is for
Attention Deficit-Hyperactivity Disorder
What is being tested?
Neurofeedback NFT and Methylphenidate MPH
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
12 sitesin 5 countries
Study dates
Aug 2016to Sep 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

12 sites in 5 countries.

Michel Du Peloux, PhD contact

062-434-1061 ext. +33

michel.du-peloux@mensiatech.com

12 sites in 5 countries

France5 sites, 5 recruiting

  • Centre Hospitalier Charles Perrens

    Bordeaux, 33076

    Stephanie Bioulac, MD/PhD, stephanie.bioulac@chu-bordeaux.fr

    Stephanie Bioulac, MD/PhD

    Recruiting

  • CHRU de Lille - Hôpital Fontan - Service de psychiatrie de l'enfant et de l'adolescent

    Lille, 59000

    Renaud Jardri, Pr, Renaud.JARDRI@chru-lille.fr

    Aesa Parenti, MD, PhD, (0)3 20 44 67 47 ext. +33, AESA.PARENTI@chru-lille.fr

    Recruiting

  • Clinique LAUTREAMONT

    Lille, 59120

    Frederic Kochman, MD/PhD, (0)82-610-9990 ext. +33, f.kochman@orpea.net

    Frederic Kochman, MD/PhD

    Recruiting

  • Hospice Civil de Lyon - Hôpital Neurologique Service de Neuro-Psychiatrie de l'Enfant

    Lyon, 59003

    Olivier Revol, MD, PhD, olivier.revol@chu-lyon.fr

    Olivier Revol, MD, PhD

    Recruiting

  • CHRU Montpellier

    Montpellier, 34000

    Diane Purper-Ouakil, MD/PhD, (0)4 67 33 60 09 ext. +33, d-purper_ouakil@chu.montpellier.fr

    Diane Purper-Ouakil, MD/PhD

    Recruiting

Other trials in France

Belgium2 sites, 2 recruiting

  • PSY Pluriel Centre europeen de psychologie medicale

    Brussels, 1080

    Laurent Victoor, MD/PhD, (0)2331-5665 ext. +32, lvictoor@psypluriel.be

    Daniel Souery, MD/PhD, (0)2331-5665 ext. +32, dsouery@psypluriel.be

    Recruiting

  • Hôpital Erasme - Cliniques universitaires de Bruxelles

    Brussels, B-1070

    Marie Delhaye, MD, PhD, (0)2 555 37 30 ext. +32, Marie.Delhaye@erasme.ulb.ac.be

    Kristell Ackerman, MD, PhD, (0)2 555 35 96 ext. +32, kristell.ackerman@erasme.ulb.ac.be

    Not yet recruiting

Other trials in Belgium

Germany2 sites, 1 recruiting

  • Universitätklinikum Erlangen

    Erlangen, Bavaria, 91052

    Terminated

  • Medical faculty of Mannheim/Heidelberg university

    Mannheim, 68159

    Daniel Brandeis, DSc/Pr, (0)621 1703 4922 ext. +49, daniel.brandeis@zi-mannheim.de

    Tobias Banaschewski, MD/PhD

    Not yet recruiting

Other trials in Germany

Switzerland2 sites, 2 recruiting

  • Clinique des Grangettes

    Geneva, 1206

    Caroline C Menache, MD/PhD, (0)22 305 0567 ext. +41, caroline.menache@grangettes.ch

    Caroline Menache, MD/PhD

    Not yet recruiting

  • Psychiatric Hospital, University of Zürich

    Zurich, CH- 8032

    Daniel Brandeis, MSc/Pr, (0)43 499 2763 ext. +41, brandeis@kjpd.uzh.ch

    Susanne Walitza, MD/MSc/Pr, (0)43 499 27 30 ext. +41, susanne.walitza@puk.zh.ch

    Not yet recruiting

Other trials in Switzerland

Spain1 site, 1 recruiting

  • Puerta de Hierro Hospital - Department of Psychiatry

    Madrid, 28400

    Hilario Blasco-Fontecilla, MD/PhD, (0)91 8503008 ext. +34, hmblasco@yahoo.es

    Hilario Blasco-Fontecilla, MD/PhD

    Recruiting

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Neurofeedback NFT, Methylphenidate MPH
Keywords
Attention deficit, Neurofeedback, ADHD, Methylphenidate
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurofeedback NFTDevice

    Also called Neurofeedback training, ADHD@Home

    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.

  • Methylphenidate MPHDrug

    Also called Methylphenidate long acting, Medikinet retard

    Drug prescribed with a first titration period until an optimal dose.

Study groups in NCT02778360
Study groupRoleWhat they receive
Neurofeedback NFTExperimentalNeurofeedback 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
Receives: Device: Neurofeedback NFT
Methylphenidate MPHActive comparatorMethylphenidate 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).
Receives: Drug: Methylphenidate MPH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 times (Day 0, Day 60, Day 90)

Secondary outcomes (18)

  1. 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

    Measured: 3 times (Day 0, Day 60, Day 90)

  2. Clinical responders

    Clinical responders are subjects who will present a decrease of the total clinician ADHD RS score of more or equal to 25%

    Measured: 1 time (Day 90)

  3. 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

    Measured: 3 times (Day 0, Day 60, Day 90)

  4. 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

    Measured: 2 times (Day 0, Day 90)

  5. Clinical Global Impression (severity) (CGI-S)

    Severity of the illness assessed by the clinician

    Measured: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)

  6. Clinical Global Impression (improvement) (CGI-I)

    Improvement of the patient's condition assessed by the clinician

    Measured: 6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)

  7. Behavior Rating Inventory of Executive Function (BRIEF)

    Executive Function Tests by the Behavior Rating Inventory of Executive Function (BRIEF)

    Measured: 2 times (Day 0, Day 90)

  8. Conners Continuous Performance Test 3rd Edition (Conners CPT 3)

    Conners Continuous Performance Test 3rd Edition

    Measured: 2 times (Day 0, Day 90)

  9. Strengths and Difficulties Questionnaire (SDQ)

    Behaviour assessment by the parents and the teacher with the Strengths and Difficulties Questionnaire

    Measured: 2 times (Day 0, Day 90)

  10. quantitative Electro-Encephalogram (qEEG)

    Quantitative electroencephalogram to assess EEG biomarkers, progress in brain modulation

    Measured: 3 times (Day 0, Day 60, Day 90)

  11. Columbia suicide severity rating scale (C-SSRS)

    Columbia suicide severity rating scale

    Measured: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)

  12. Sleep Disturbance Scale for Children (SDSC)

    Sleep Disturbance Scale for Children

    Measured: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)

  13. Pediatric adverse event rating scale (PAERS)

    Pediatric adverse event rating scale

    Measured: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)

  14. 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).

    Measured: 1 time (Day 0)

  15. Medical/surgical history

    Assessment especially related to the eligibility criteria

    Measured: 1 time (Day 0)

  16. 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.

    Measured: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)

  17. 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.

    Measured: 6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)

  18. 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

    Measured: 2 times (Day 0, Day 90)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionSep 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
179 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02778360
Sponsor's protocol ID
Newrofeed
Acronym
Newrofeed
Status last verified
Apr 2017
First submitted
12 May 2016
Last updated
5 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Purper-Ouakil D, Blasco-Fontecilla H, Ros T, Acquaviva E, Banaschewski T, Baumeister S, Bousquet E, Bussalb A, Delhaye M, Delorme R, Drechsler R, Goujon A, Hage A, Kaiser A, Mayaud L, Mechler K, Menache C, Revol O, Tagwerker F, Walitza S, Werling AM, Bioulac S, Brandeis D. Personalized at-home neurofeedback compared to long-acting methylphenidate in children with ADHD: NEWROFEED, a European randomized noninferiority trial. J Child Psychol Psychiatry. 2022 Feb;63(2):187-198. doi: 10.1111/jcpp.13462. Epub 2021 Jun 24.

    PubMed 34165190

  • Bioulac S, Purper-Ouakil D, Ros T, Blasco-Fontecilla H, Prats M, Mayaud L, Brandeis D. Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD. BMC Psychiatry. 2019 Aug 1;19(1):237. doi: 10.1186/s12888-019-2218-0.

    PubMed 31370811

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Neurofeedback NFT and Methylphenidate MPH in people with Attention Deficit-Hyperactivity Disorder, run by Mensia Technologies SA at 12 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France, Belgium, Germany, Switzerland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michel Du Peloux, PhD (062-434-1061 ext. +33, michel.du-peloux@mensiatech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02778360, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.

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