EUCTR2016-002171-94-BE
Active, not recruiting
Phase 1
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 - Newrofeed
Mensia Technologies SA0 sites179 target enrollmentJanuary 20, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Attention Deficit-Hyperactivity Disorder
- Sponsor
- Mensia Technologies SA
- Enrollment
- 179
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
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
- •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
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
Outcomes
Primary Outcomes
Not specified
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