Clinical trial NCT02778360: Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) in Attention-Deficit/Hyperactivity Disorder
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Attention Deficit-Hyperactivity Disorder
Keywords: Attention deficit
Neurofeedback
ADHD
Methylphenidate
Lead sponsor: Mensia Technologies SA
Sponsor class: INDUSTRY
Collaborators: name: European Union H2020 SME Instrument
First posted: 2016-05-19
Enrollment: 179
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from Day 0 at Day 90 of the total score of the ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV)
timeFrame: 3 times (Day 0, Day 60, Day 90)
Secondary outcomes:
measure: ADHD RS IV Inattention and Hyperactivity Sub-Scores
timeFrame: 3 times (Day 0, Day 60, Day 90)
measure: Clinical responders
timeFrame: 1 time (Day 90)
measure: Parents ADHD RS IV Total, Inattention and Hyperactivity Scores
timeFrame: 3 times (Day 0, Day 60, Day 90)
measure: Teacher ADHD RS IV Total, Inattention and Hyperactivity Scores
timeFrame: 2 times (Day 0, Day 90)
measure: Clinical Global Impression (severity) (CGI-S)
timeFrame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
measure: Clinical Global Impression (improvement) (CGI-I)
timeFrame: 6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: 2 times (Day 0, Day 90)
measure: Conners Continuous Performance Test 3rd Edition (Conners CPT 3)
timeFrame: 2 times (Day 0, Day 90)
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 2 times (Day 0, Day 90)
measure: quantitative Electro-Encephalogram (qEEG)
timeFrame: 3 times (Day 0, Day 60, Day 90)
measure: Columbia suicide severity rating scale (C-SSRS)
timeFrame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
measure: Sleep Disturbance Scale for Children (SDSC)
timeFrame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
measure: Pediatric adverse event rating scale (PAERS)
timeFrame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
measure: Physical examination
timeFrame: 1 time (Day 0)
measure: Medical/surgical history
timeFrame: 1 time (Day 0)
measure: Concomitant treatments collection
timeFrame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
measure: Adverse events collection
timeFrame: 6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
measure: Child Health and Illness Profile, Child Edition (CHIP-CE)
timeFrame: 2 times (Day 0, Day 90)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: PSY Pluriel Centre europeen de psychologie medicale
city: Bruxelles
country: Belgium
facility: Hôpital Erasme - Cliniques universitaires de Bruxelles
city: Bordeaux
country: France
facility: Centre Hospitalier Charles Perrens
city: Lille
country: France
facility: CHRU de Lille - Hôpital Fontan - Service de psychiatrie de l'enfant et de l'adolescent
city: Lille
country: France
facility: Clinique LAUTREAMONT
city: Lyon
country: France
facility: Hospice Civil de Lyon - Hôpital Neurologique Service de Neuro-Psychiatrie de l'Enfant
city: Montpellier
country: France
facility: CHRU Montpellier
city: Erlangen
country: Germany
facility: Universitätklinikum Erlangen
state: Bayern
city: Mannheim
country: Germany
facility: Medical faculty of Mannheim/Heidelberg university
city: Madrid
country: Spain
facility: Puerta de Hierro Hospital - Department of Psychiatry
city: Genève
country: Switzerland
facility: Clinique des Grangettes
city: Zürich
country: Switzerland
facility: Psychiatric Hospital, University of Zürich
Study officials:
affiliation: Mensia Technologies
name: Michel Du Peloux, PhD
role: STUDY_DIRECTOR
affiliation: CHRU Montpellier
name: Diane Purper-Ouakil, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.