Effectiveness of a personalized Training device (ADHD@Home) as compared with a drug (Methylphenidate) in the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 179

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 179
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-ADHD hyperactive/Impulsive without inattention component
-Established diagnosis of epilepsy or other neurological disorders
-Severe 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Furthermore, it is aimed to learn more about the mechanisms underlying Neurofeedback (including the study of biomarkers);Primary end point(s): change from baseline (inclusion visit Day 0) to end of treatment (last visit Day 90 more or less 10 days) in the Clinician ADHD RS IV total score;Timepoint(s) of evaluation of this end point: Day 0, Day 60, and Day 90

Secondary Outcome Measures

Name	Time	Method

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