Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Evaluation of the relative effect on symptoms of inattention between the two proposed training techniques, A and B, with the ADHD Rating Scale in children with ADHD
研究概览
简要总结
This project aims to assess the evolution of symptoms in ADHD children from 8 to 17 years, with various types of attention training.
Different groups A, B and C will be evaluated: the first with Neurofeedback training, the second with a similar training but not indexed on brain activity and the third without training.
30 patients will be randomly assigned to groups A and B according to a ratio 2:1.
Others patients who meet the same criteria but for logistical reasons cannot comply with the training constraints will be assigned to group C.
Children included in groups A and B will participate in training sessions (Neurofeedback and control training, respectively) as well as in four evaluation sessions. Children in group C will only participate in evaluation sessions (baseline control group).
Patients of groups A and B will be followed over 6 months: 4 months of training and a follow-up evaluation 2 months after training.
Patients of group C will be followed each 2 months for 6 months. This study uses electro-encephalography measures, serious video game, neuropsychological tests and questionnaires.
It also uses actigraphy measures to evaluate sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and teenagers aged from 8 to 17 years' old
- •Children and teenagers with a deficit attention disorder with or without hyperactivity, in the mixed form or in a pure inattentive form according to Diagnostique et Statistique des troubles Mentaux (DSM)-V.
- •Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) ≥ 80 of WISC IV or V test, not older than two years.
- •Children and teenagers without psychostimulant treatment
- •Children and teenagers with psychostimulant treatment agreed to achieve a therapeutic break at each visit day and with a stable dose during all the study.
- •Children and teenagers whose parents have agreed and signed informed consent form of the study.
排除标准
- •Children aged less than 8 and teenagers are more than 18 years' old.
- •Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) < 80 of WISC IV or V test, not older than two years.
- •Children and teenagers with developmental disorder except "Dys" disorders.
- •Children and teenagers with pure hyperactivity (without attentional deficit)
- •Children and teenagers with epilepsy except benign epilepsies (without brain damage), free of crisis for two years and without treatment.
- •Children and teenagers with ADHD with conduct disorders and aggression
- •Children and teenagers with ADHD and Tourette's syndrome.
- •Patients treated by anti / epilepsy or psychotropic treatments (with the exception of psychostimulant treatment).
- •Patients with psychostimulant treatment and whose parents aren't agreed to achieve a therapeutic break at each visit day.
- •Patients with visual deficiency uncorrectable with lenses or glasses.
研究组 & 干预措施
Group A
Children will be assigned to this group in a random fashion according to a ratio 2:1 with respect to group B (see below).
20 subjects will be included in this group.
干预措施: Neurofeedback training (Other)
Group B
Children will be assigned in this group in a random fashion. 10 subjects will be included in this group.
干预措施: Active Sham control (Other)
Group C
Will be included in this group children who meet the inclusion criteria and who, with their families, are motivated to participate in the study but cannot claim to be part of groups A or B (because of logistical constraints: living too far away to comply with the frequency of the visits required by the training).
Group C allows to follow the natural evolution of children with ADHD with no intervention.
干预措施: Baseline control group (Other)
结局指标
主要结局
Evaluation of the relative effect on symptoms of inattention between the two proposed training techniques, A and B, with the ADHD Rating Scale in children with ADHD
时间窗: every two months over six months.
Questions with odd numbers interested in the dimension "inattentive" will particularly be studied. The investigator expect an improvement in the type of score: ''ADHD-Inattentive'' children in group A compared to children in Group B. More specifically, he expect to improve responses to questions number 1,3,5,7,9,11,13,15 and 17. By definition, an evolving response would be to move from " 2=Often; 3=Very often" to " 1=Sometimes; 0=Rarely/Never".
次要结局
- Compare the effects of the two types of trainings on the hyperactivity symptoms in ADHD children using neuropsychological assessments.(every two months over six months)
- Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.(every two months over six months)
- Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)(every two months over six months)
- Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.(every two months over six months)
- Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)(every two months over six months)
- Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.(every two months over six months)
- Evaluate the impact of the trainings on the sleep quality in ADHD children.(every two months over six months.)
- Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children(every months over six months.)
- Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children(every months over six months.)
- neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children(every two months over six months)
- neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children(every two months over six months)
- neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children(every two months over six months)
- Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.(every two months over six months)
- Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.(every two months over six months)
- Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.(every two months over six months)
- Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))(every two months over six months)
- Evaluating the impact of the trainings on the quality of life in ADHD children.(every two months over six months)