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

NCT02778360 | Unknown Phase 1

• 1 other identifier: Newrofeed
• Study Type: interventional
• Target: 179
• Locations: 5 countries
• Sites: 12

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.

Conditions

Attention Deficit-Hyperactivity Disorder

Keywords

Attention deficit; Neurofeedback; ADHD; Methylphenidate

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (18)

• ADHD RS IV Inattention and Hyperactivity Sub-Scores

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

• Clinical responders

  1 time (Day 90)

• Parents ADHD RS IV Total, Inattention and Hyperactivity Scores

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

• Teacher ADHD RS IV Total, Inattention and Hyperactivity Scores

  2 times (Day 0, Day 90)

• Clinical Global Impression (severity) (CGI-S)

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

Study Arms (2)

Neurofeedback NFT

EXPERIMENTAL

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

Methylphenidate MPH

ACTIVE COMPARATOR

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

Interventions

Neurofeedback NFT DEVICE

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.

Also known as: Neurofeedback training, ADHD@Home

Neurofeedback NFT

Methylphenidate MPH DRUG

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

Also known as: Methylphenidate long acting, Medikinet retard

Methylphenidate MPH

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mensia Technologies SA: lead
• European Union H2020 SME Instrument: collaborator

Study Sites (12)

PSY Pluriel Centre europeen de psychologie medicale

Brussels, 1080, Belgium

RECRUITING

Hôpital Erasme - Cliniques universitaires de Bruxelles

Brussels, B-1070, Belgium

NOT YET RECRUITING

Centre Hospitalier Charles Perrens

Bordeaux, 33076, France

RECRUITING

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

Lille, 59000, France

RECRUITING

Clinique LAUTREAMONT

Lille, 59120, France

RECRUITING

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

Lyon, 59003, France

RECRUITING

CHRU Montpellier

Montpellier, 34000, France

RECRUITING

Universitätklinikum Erlangen

Erlangen, Bavaria, 91052, Germany

TERMINATED

Medical faculty of Mannheim/Heidelberg university

Mannheim, 68159, Germany

NOT YET RECRUITING

Puerta de Hierro Hospital - Department of Psychiatry

Madrid, 28400, Spain

RECRUITING

Clinique des Grangettes

Geneva, 1206, Switzerland

NOT YET RECRUITING

Psychiatric Hospital, University of Zürich

Zurich, CH- 8032, Switzerland

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 34165190 DERIVED

• 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.

  PMID: 31370811 DERIVED

Related Links

• Opinons on NFT for ADHD

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michel Du Peloux, PhD

  Mensia Technologies

  STUDY DIRECTOR

• Diane Purper-Ouakil, MD/PhD

  CHRU Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Du Peloux, PhD

CONTACT

062-434-1061; michel.du-peloux@mensiatech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 19, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

CH (2); FR (5); DE (2); BE (2); ES (1)