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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2017

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 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
  • Active Comparator: 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).

Clinical Trial Outcome Measures

Primary Measures

  • Change from Day 0 at Day 90 of the total score of the ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV)
    • Time Frame: 3 times (Day 0, Day 60, Day 90)
    • ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): total score assessed by the clinician

Secondary Measures

  • ADHD RS IV Inattention and Hyperactivity Sub-Scores
    • Time Frame: 3 times (Day 0, Day 60, Day 90)
    • ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): Inattention and Hyperactivity sub-scores assessed by the clinician
  • Clinical responders
    • Time Frame: 1 time (Day 90)
    • 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
    • Time Frame: 3 times (Day 0, Day 60, Day 90)
    • 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
    • Time Frame: 2 times (Day 0, Day 90)
    • 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)
    • Time Frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
    • Severity of the illness assessed by the clinician
  • Clinical Global Impression (improvement) (CGI-I)
    • Time Frame: 6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
    • Improvement of the patient’s condition assessed by the clinician
  • Behavior Rating Inventory of Executive Function (BRIEF)
    • Time Frame: 2 times (Day 0, Day 90)
    • Executive Function Tests by the Behavior Rating Inventory of Executive Function (BRIEF)
  • Conners Continuous Performance Test 3rd Edition (Conners CPT 3)
    • Time Frame: 2 times (Day 0, Day 90)
    • Conners Continuous Performance Test 3rd Edition
  • Strengths and Difficulties Questionnaire (SDQ)
    • Time Frame: 2 times (Day 0, Day 90)
    • Behaviour assessment by the parents and the teacher with the Strengths and Difficulties Questionnaire
  • quantitative Electro-Encephalogram (qEEG)
    • Time Frame: 3 times (Day 0, Day 60, Day 90)
    • Quantitative electroencephalogram to assess EEG biomarkers, progress in brain modulation
  • Columbia suicide severity rating scale (C-SSRS)
    • Time Frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
    • Columbia suicide severity rating scale
  • Sleep Disturbance Scale for Children (SDSC)
    • Time Frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
    • Sleep Disturbance Scale for Children
  • Pediatric adverse event rating scale (PAERS)
    • Time Frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
    • Pediatric adverse event rating scale
  • Physical examination
    • Time Frame: 1 time (Day 0)
    • 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
    • Time Frame: 1 time (Day 0)
    • Assessment especially related to the eligibility criteria
  • Concomitant treatments collection
    • Time Frame: 7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
    • 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
    • Time Frame: 6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90)
    • 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)
    • Time Frame: 2 times (Day 0, Day 90)
    • Measure of the quality of life by the parents with the CHIP-CE parents report form

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 13 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mensia Technologies SA
  • Collaborator
    • European Union H2020 SME Instrument
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michel Du Peloux, PhD, Study Director, Mensia Technologies
    • Diane Purper-Ouakil, MD/PhD, Principal Investigator, CHRU Montpellier
  • Overall Contact(s)
    • Michel Du Peloux, PhD, 062-434-1061, michel.du-peloux@mensiatech.com

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