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

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mensia Technologies SA
• Collaborator: European Union H2020 SME Instrument
• Treatments: Methylphenidate

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