Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) in Attention-Deficit/Hyperactivity Disorder
NCT ID: NCT02778360
Last Updated: 2017-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
179 participants
INTERVENTIONAL
2016-08-31
2017-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
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).
Methylphenidate MPH
Drug prescribed with a first titration period until an optimal dose.
Interventions
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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.
Methylphenidate MPH
Drug prescribed with a first titration period until an optimal dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
7 Years
13 Years
ALL
No
Sponsors
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European Union H2020 SME Instrument
UNKNOWN
Mensia Technologies SA
INDUSTRY
Responsible Party
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Principal Investigators
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Michel Du Peloux, PhD
Role: STUDY_DIRECTOR
Mensia Technologies
Diane Purper-Ouakil, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
CHRU Montpellier
Locations
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PSY Pluriel Centre europeen de psychologie medicale
Brussels, , Belgium
Hôpital Erasme - Cliniques universitaires de Bruxelles
Brussels, , Belgium
Centre Hospitalier Charles Perrens
Bordeaux, , France
CHRU de Lille - Hôpital Fontan - Service de psychiatrie de l'enfant et de l'adolescent
Lille, , France
Clinique LAUTREAMONT
Lille, , France
Hospice Civil de Lyon - Hôpital Neurologique Service de Neuro-Psychiatrie de l'Enfant
Lyon, , France
CHRU Montpellier
Montpellier, , France
Universitätklinikum Erlangen
Erlangen, Bavaria, Germany
Medical faculty of Mannheim/Heidelberg university
Mannheim, , Germany
Puerta de Hierro Hospital - Department of Psychiatry
Madrid, , Spain
Clinique des Grangettes
Geneva, , Switzerland
Psychiatric Hospital, University of Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Tobias Banaschewski, MD/PhD
Role: backup
References
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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.
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.
Related Links
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Opinons on NFT for ADHD
Other Identifiers
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Newrofeed
Identifier Type: -
Identifier Source: org_study_id
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