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
概览
- 阶段
- 1 期
- 干预措施
- Neurofeedback NFT
- 疾病 / 适应症
- Attention Deficit-Hyperactivity Disorder
- 发起方
- Mensia Technologies SA
- 入组人数
- 179
- 试验地点
- 12
- 主要终点
- Change from Day 0 at Day 90 of the total score of the ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV)
- 最后更新
- 9年前
概览
简要总结
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.
详细描述
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. Furthermore, it is aimed to learn more about the mechanisms underlying NeuroFeedback. The study is prospective, multicentric (9 centres), randomised, reference drug-controlled. ADHD@Home is a neuromarkerTM-based personalized medicine device to treat children suffering from Attention Deficit Hyperactivity Disorders (ADHD) with Neurofeedback Training (NFT) based on real time electroencephalography (EEG) signal. Neurofeedback Training is based on direct training of brain function, by which the brain learns to function more efficiently. For each session of the ADHD@Home solution, the child is trained to modulate his brain activity in a serious game, which is a real-time metaphor of the EEG biomarker that needs to be 'normalized', following a typical operant learning process.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Neurofeedback NFT
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
干预措施: Neurofeedback NFT
Methylphenidate MPH
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).
干预措施: Methylphenidate MPH
结局指标
主要结局
Change from Day 0 at Day 90 of the total score of the ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV)
时间窗: 3 times (Day 0, Day 60, Day 90)
ADHD RS IV (Attention Deficit Hyperactivity Disorder Rating Scale IV): total score assessed by the clinician
次要结局
- Child Health and Illness Profile, Child Edition (CHIP-CE)(2 times (Day 0, Day 90))
- Teacher ADHD RS IV Total, Inattention and Hyperactivity Scores(2 times (Day 0, Day 90))
- Clinical Global Impression (severity) (CGI-S)(7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90))
- ADHD RS IV Inattention and Hyperactivity Sub-Scores(3 times (Day 0, Day 60, Day 90))
- Clinical responders(1 time (Day 90))
- Parents ADHD RS IV Total, Inattention and Hyperactivity Scores(3 times (Day 0, Day 60, Day 90))
- Clinical Global Impression (improvement) (CGI-I)(6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90))
- Behavior Rating Inventory of Executive Function (BRIEF)(2 times (Day 0, Day 90))
- Conners Continuous Performance Test 3rd Edition (Conners CPT 3)(2 times (Day 0, Day 90))
- Strengths and Difficulties Questionnaire (SDQ)(2 times (Day 0, Day 90))
- quantitative Electro-Encephalogram (qEEG)(3 times (Day 0, Day 60, Day 90))
- Columbia suicide severity rating scale (C-SSRS)(7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90))
- Sleep Disturbance Scale for Children (SDSC)(7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90))
- Pediatric adverse event rating scale (PAERS)(7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90))
- Physical examination(1 time (Day 0))
- Medical/surgical history(1 time (Day 0))
- Adverse events collection(6 times (Day 7, Day 14, Day 21, Day 28, Day 60, Day 90))
- Concomitant treatments collection(7 times (Day 0, Day 7, Day 14, Day 21, Day 28, Day 60, Day 90))