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 个研究点目标入组 179 人开始时间: 2016年7月15日最近更新: 2018年7月23日

适应症

试验速览

暂无简介。

•-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

•-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

发起方

Mensia Technologies SA