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

Attention Deficit-Hyperactivity Disorder Clinical Trial

— Newrofeed  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02778360
• Other study ID #: Newrofeed
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 12, 2016
• Last updated: April 3, 2017
• Start date: August 2016
• Est. completion date: September 2017

Study information

• Verified date: April 2017
• Source: Mensia Technologies SA
• Contact: Michel Du Peloux, PhD
• Phone: 062-434-1061
• Email: michel.du-peloux[@]mensiatech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 179
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit-Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

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.

Drug:
• Methylphenidate MPH
Drug prescribed with a first titration period until an optimal dose.

Locations

Country	Name	City	State
Belgium	Hôpital Erasme - Cliniques universitaires de Bruxelles	Bruxelles
Belgium	PSY Pluriel Centre europeen de psychologie medicale	Bruxelles
France	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
Germany	Universitätklinikum Erlangen	Erlangen	Bayern
Germany	Medical faculty of Mannheim/Heidelberg university	Mannheim
Spain	Puerta de Hierro Hospital - Department of Psychiatry	Madrid
Switzerland	Clinique des Grangettes	Genève
Switzerland	Psychiatric Hospital, University of Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Mensia Technologies SA	European Union H2020 SME Instrument

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	3 times (Day 0, Day 60, Day 90)
Secondary	Clinical responders	Clinical responders are subjects who will present a decrease of the total clinician ADHD RS score of more or equal to 25%	1 time (Day 90)
Secondary	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	3 times (Day 0, Day 60, Day 90)
Secondary	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	2 times (Day 0, Day 90)
Secondary	Clinical Global Impression (severity) (CGI-S)	Severity of the illness assessed by the clinician	7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Secondary	Clinical Global Impression (improvement) (CGI-I)	Improvement of the patient's condition assessed by the clinician	6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Secondary	Behavior Rating Inventory of Executive Function (BRIEF)	Executive Function Tests by the Behavior Rating Inventory of Executive Function (BRIEF)	2 times (Day 0, Day 90)
Secondary	Conners Continuous Performance Test 3rd Edition (Conners CPT 3)	Conners Continuous Performance Test 3rd Edition	2 times (Day 0, Day 90)
Secondary	Strengths and Difficulties Questionnaire (SDQ)	Behaviour assessment by the parents and the teacher with the Strengths and Difficulties Questionnaire	2 times (Day 0, Day 90)
Secondary	quantitative Electro-Encephalogram (qEEG)	Quantitative electroencephalogram to assess EEG biomarkers, progress in brain modulation	3 times (Day 0, Day 60, Day 90)
Secondary	Columbia suicide severity rating scale (C-SSRS)	Columbia suicide severity rating scale	7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Secondary	Sleep Disturbance Scale for Children (SDSC)	Sleep Disturbance Scale for Children	7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Secondary	Pediatric adverse event rating scale (PAERS)	Pediatric adverse event rating scale	7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Secondary	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).	1 time (Day 0)
Secondary	Medical/surgical history	Assessment especially related to the eligibility criteria	1 time (Day 0)
Secondary	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.	7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Secondary	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.	6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Secondary	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	2 times (Day 0, Day 90)

External Links

•   Opinons on NFT for ADHD