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

Primary Purpose

Attention Deficit-Hyperactivity Disorder

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Neurofeedback NFT
Methylphenidate MPH
Sponsored by
Mensia Technologies SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit-Hyperactivity Disorder focused on measuring Attention deficit, Neurofeedback, ADHD, Methylphenidate

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PSY Pluriel Centre europeen de psychologie medicaleRecruiting
  • Hôpital Erasme - Cliniques universitaires de Bruxelles
  • Centre Hospitalier Charles PerrensRecruiting
  • CHRU de Lille - Hôpital Fontan - Service de psychiatrie de l'enfant et de l'adolescentRecruiting
  • Clinique LAUTREAMONTRecruiting
  • Hospice Civil de Lyon - Hôpital Neurologique Service de Neuro-Psychiatrie de l'EnfantRecruiting
  • CHRU MontpellierRecruiting
  • Universitätklinikum Erlangen
  • Medical faculty of Mannheim/Heidelberg university
  • Puerta de Hierro Hospital - Department of PsychiatryRecruiting
  • Clinique des Grangettes
  • Psychiatric Hospital, University of Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neurofeedback NFT

Methylphenidate MPH

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2016
Last Updated
April 3, 2017
Sponsor
Mensia Technologies SA
Collaborators
European Union H2020 SME Instrument
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1. Study Identification

Unique Protocol Identification Number
NCT02778360
Brief Title
Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) in Attention-Deficit/Hyperactivity Disorder
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mensia Technologies SA
Collaborators
European Union H2020 SME Instrument

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit-Hyperactivity Disorder
Keywords
Attention deficit, Neurofeedback, ADHD, Methylphenidate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
179 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback NFT
Arm Type
Experimental
Arm Description
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
Arm Title
Methylphenidate MPH
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Neurofeedback NFT
Other Intervention Name(s)
Neurofeedback training, ADHD@Home
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate MPH
Other Intervention Name(s)
Methylphenidate long acting, Medikinet retard
Intervention Description
Drug prescribed with a first titration period until an optimal dose.
Primary Outcome Measure Information:
Title
Change from Day 0 at Day 90 of the total score of the ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV)
Description
ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): total score assessed by the clinician
Time Frame
3 times (Day 0, Day 60, Day 90)
Secondary Outcome Measure Information:
Title
ADHD RS IV Inattention and Hyperactivity Sub-Scores
Description
ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): Inattention and Hyperactivity sub-scores assessed by the clinician
Time Frame
3 times (Day 0, Day 60, Day 90)
Title
Clinical responders
Description
Clinical responders are subjects who will present a decrease of the total clinician ADHD RS score of more or equal to 25%
Time Frame
1 time (Day 90)
Title
Parents ADHD RS IV Total, Inattention and Hyperactivity Scores
Description
ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): Total, Inattention and Hyperactivity scores assessed by the parents
Time Frame
3 times (Day 0, Day 60, Day 90)
Title
Teacher ADHD RS IV Total, Inattention and Hyperactivity Scores
Description
ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): Total, Inattention and Hyperactivity scores assessed by the teacher
Time Frame
2 times (Day 0, Day 90)
Title
Clinical Global Impression (severity) (CGI-S)
Description
Severity of the illness assessed by the clinician
Time Frame
7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Title
Clinical Global Impression (improvement) (CGI-I)
Description
Improvement of the patient's condition assessed by the clinician
Time Frame
6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Title
Behavior Rating Inventory of Executive Function (BRIEF)
Description
Executive Function Tests by the Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame
2 times (Day 0, Day 90)
Title
Conners Continuous Performance Test 3rd Edition (Conners CPT 3)
Description
Conners Continuous Performance Test 3rd Edition
Time Frame
2 times (Day 0, Day 90)
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
Behaviour assessment by the parents and the teacher with the Strengths and Difficulties Questionnaire
Time Frame
2 times (Day 0, Day 90)
Title
quantitative Electro-Encephalogram (qEEG)
Description
Quantitative electroencephalogram to assess EEG biomarkers, progress in brain modulation
Time Frame
3 times (Day 0, Day 60, Day 90)
Title
Columbia suicide severity rating scale (C-SSRS)
Description
Columbia suicide severity rating scale
Time Frame
7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Title
Sleep Disturbance Scale for Children (SDSC)
Description
Sleep Disturbance Scale for Children
Time Frame
7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Title
Pediatric adverse event rating scale (PAERS)
Description
Pediatric adverse event rating scale
Time Frame
7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Title
Physical examination
Description
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).
Time Frame
1 time (Day 0)
Title
Medical/surgical history
Description
Assessment especially related to the eligibility criteria
Time Frame
1 time (Day 0)
Title
Concomitant treatments collection
Description
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.
Time Frame
7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Title
Adverse events collection
Description
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.
Time Frame
6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
Title
Child Health and Illness Profile, Child Edition (CHIP-CE)
Description
Measure of the quality of life by the parents with the CHIP-CE parents report form
Time Frame
2 times (Day 0, Day 90)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Du Peloux, PhD
Phone
062-434-1061
Ext
+33
Email
michel.du-peloux@mensiatech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Du Peloux, PhD
Organizational Affiliation
Mensia Technologies
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Diane Purper-Ouakil, MD/PhD
Organizational Affiliation
CHRU Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
PSY Pluriel Centre europeen de psychologie medicale
City
Bruxelles
ZIP/Postal Code
1080
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Victoor, MD/PhD
Phone
(0)2331-5665
Ext
+32
Email
lvictoor@psypluriel.be
First Name & Middle Initial & Last Name & Degree
Daniel Souery, MD/PhD
Phone
(0)2331-5665
Ext
+32
Email
dsouery@psypluriel.be
First Name & Middle Initial & Last Name & Degree
Laurent Victoor, MD/PhD
Facility Name
Hôpital Erasme - Cliniques universitaires de Bruxelles
City
Bruxelles
ZIP/Postal Code
B-1070
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Delhaye, MD, PhD
Phone
(0)2 555 37 30
Ext
+32
Email
Marie.Delhaye@erasme.ulb.ac.be
First Name & Middle Initial & Last Name & Degree
Kristell Ackerman, MD, PhD
Phone
(0)2 555 35 96
Ext
+32
Email
kristell.ackerman@erasme.ulb.ac.be
First Name & Middle Initial & Last Name & Degree
Marie Delhaye, MD, PhD
Facility Name
Centre Hospitalier Charles Perrens
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Bioulac, MD/PhD
Email
stephanie.bioulac@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Stephanie Bioulac, MD/PhD
Facility Name
CHRU de Lille - Hôpital Fontan - Service de psychiatrie de l'enfant et de l'adolescent
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud Jardri, Pr
Email
Renaud.JARDRI@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Aesa Parenti, MD, PhD
Phone
(0)3 20 44 67 47
Ext
+33
Email
AESA.PARENTI@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Renaud Jardri, Pr
Facility Name
Clinique LAUTREAMONT
City
Lille
ZIP/Postal Code
59120
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Kochman, MD/PhD
Phone
(0)82-610-9990
Ext
+33
Email
f.kochman@orpea.net
First Name & Middle Initial & Last Name & Degree
Frederic Kochman, MD/PhD
Facility Name
Hospice Civil de Lyon - Hôpital Neurologique Service de Neuro-Psychiatrie de l'Enfant
City
Lyon
ZIP/Postal Code
59003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Revol, MD, PhD
Email
olivier.revol@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Olivier Revol, MD, PhD
Facility Name
CHRU Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Purper-Ouakil, MD/PhD
Phone
(0)4 67 33 60 09
Ext
+33
Email
d-purper_ouakil@chu.montpellier.fr
First Name & Middle Initial & Last Name & Degree
Diane Purper-Ouakil, MD/PhD
Facility Name
Universitätklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91052
Country
Germany
Individual Site Status
Terminated
Facility Name
Medical faculty of Mannheim/Heidelberg university
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Brandeis, DSc/Pr
Phone
(0)621 1703 4922
Ext
+49
Email
daniel.brandeis@zi-mannheim.de
First Name & Middle Initial & Last Name & Degree
Tobias Banaschewski, MD/PhD
First Name & Middle Initial & Last Name & Degree
Tobias Banaschewski, MD/PhD
Facility Name
Puerta de Hierro Hospital - Department of Psychiatry
City
Madrid
ZIP/Postal Code
28400
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilario Blasco-Fontecilla, MD/PhD
Phone
(0)91 8503008
Ext
+34
Email
hmblasco@yahoo.es
First Name & Middle Initial & Last Name & Degree
Hilario Blasco-Fontecilla, MD/PhD
Facility Name
Clinique des Grangettes
City
Genève
ZIP/Postal Code
1206
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline C Menache, MD/PhD
Phone
(0)22 305 0567
Ext
+41
Email
caroline.menache@grangettes.ch
First Name & Middle Initial & Last Name & Degree
Caroline Menache, MD/PhD
Facility Name
Psychiatric Hospital, University of Zürich
City
Zürich
ZIP/Postal Code
CH- 8032
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Brandeis, MSc/Pr
Phone
(0)43 499 2763
Ext
+41
Email
brandeis@kjpd.uzh.ch
First Name & Middle Initial & Last Name & Degree
Susanne Walitza, MD/MSc/Pr
Phone
(0)43 499 27 30
Ext
+41
Email
susanne.walitza@puk.zh.ch
First Name & Middle Initial & Last Name & Degree
Susanne Walitza, MD/MSc/Pr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34165190
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.
Results Reference
derived
PubMed Identifier
31370811
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.
Results Reference
derived
Links:
URL
http://www.mensiatech.com/neurofeedbackinadhd/
Description
Opinons on NFT for ADHD

Learn more about this trial

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

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