Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) in Attention-Deficit/Hyperactivity Disorder (Newrofeed)
Attention Deficit-Hyperactivity Disorder
About this trial
This is an interventional treatment trial for Attention Deficit-Hyperactivity Disorder focused on measuring Attention deficit, Neurofeedback, ADHD, Methylphenidate
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
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
Experimental
Active Comparator
Neurofeedback NFT
Methylphenidate MPH
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).