NEUROFEEDBACK on Event-Related Potential (ERP) (MyB)
2019年10月28日 更新者：Hospices Civils de Lyon
Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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.
研究概览
研究类型
介入性
注册 (实际的)
52
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Bron、法国、69500
- Hospices Civils de Lyon
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
Children in group A will receive BCI-based training implemented through original P300-based controlled games. They will attend 30 1-hour long training sessions at a pace of 2 sessions per week. Each session includes: installation of the child, the EEG system and an eye-tracking system, a 5-minutes relaxation phase, a short EEG recording at rest, a brief reminder of the instructions, 30 minutes of training by playing video games and finally a time for the child to wash her/his hair. Moreover, 4 neuropsychological sessions will complement the 30 training sessions. During these sessions neuropsychological tests and quality of life questionnaires will be answered. |
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有源比较器：Group B
Children will be assigned in this group in a random fashion.
10 subjects will be included in this group.
|
Children in group B will receive a training that is not based on brain activity, but in a blind fashion. They will attend 30 1-hour long training sessions at a pace of 2 sessions per week. Each session includes: installation of the child, setting up the EEG and eye-tracking systems, a 5-minutes relaxation phase, short EEG recording at rest, a brief reminder of the instructions, 30 minutes of video game based training and finally a time for the child to wash her/his hair. Besides, 4 neuropsychological sessions will complement the 30 training sessions. During these sessions neuropsychological tests and quality of life questionnaires will be performed. |
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有源比较器：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. |
The children included in this group will not receive any training.
They only take part to the 4 neuropsychological sessions.
Like others, they will attend 1 neuropsychological session every two months over six months.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
大体时间：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".
|
every two months over six months.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
大体时间：every months over six months.
|
ADHD Rating Scale (questions with odd numbers) will be performed ADHD children from groups A, B and C will be compared
|
every months over six months.
|
|
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
大体时间：every months over six months.
|
Bron/Lyon Attention Stability test (BLAST) test will be performed ADHD children from groups A, B and C will be compared
|
every months over six months.
|
|
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
大体时间：every months over six months.
|
Wechsler Intelligence Scale for Children (WISC) subtests will be performed ADHD children from groups A, B and C will be compared
|
every months over six months.
|
|
Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children
大体时间：every months over six months.
|
Wechsler Intelligence Scale for Children (WISC) will be performed ADHD children from groups A, B and C will be compared
|
every months over six months.
|
|
Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children
大体时间：every months over six months.
|
ADHD Rating Scale (questions with odd numbers) will be performed ADHD children from groups A, B and C will be compared
|
every months over six months.
|
|
Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children
大体时间：every months over six months.
|
Bron/Lyon Attention Stability test (BLAST) will be performed ADHD children from groups A, B and C will be compared
|
every months over six months.
|
|
Compare the effects of the two types of trainings on the hyperactivity symptoms in ADHD children using neuropsychological assessments.
大体时间：every two months over six months
|
ADHD Rating Scale (questions with even numbers), Test d'évaluation de l'Attention (TAP) and Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared
|
every two months over six months
|
|
neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children
大体时间：every two months over six months
|
ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared
|
every two months over six months
|
|
neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children
大体时间：every two months over six months
|
Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared
|
every two months over six months
|
|
neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children
大体时间：every two months over six months
|
Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared
|
every two months over six months
|
|
neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children
大体时间：every two months over six months
|
Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared
|
every two months over six months
|
|
neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children
大体时间：every two months over six months
|
Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared
|
every two months over six months
|
|
neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children
大体时间：every two months over six months
|
ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared
|
every two months over six months
|
|
neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children
大体时间：every two months over six months
|
Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared
|
every two months over six months
|
|
neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children
大体时间：every two months over six months
|
ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared
|
every two months over six months
|
|
neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children
大体时间：every two months over six months
|
Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
TAP will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
CPT will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
BLAST will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
ADHD Rating Scale (questions with odd numbers)will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
TAP will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
CPT will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
BLAST will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
TAP will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
CPT will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
BLAST will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
大体时间：every two months over six months
|
ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
大体时间：every two months over six months
|
TAP will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
大体时间：every two months over six months
|
BLAST will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
大体时间：every two months over six months
|
Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
TAP will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
BLAST will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
大体时间：every two months over six months
|
ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
大体时间：every two months over six months
|
TAP will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
大体时间：every two months over six months
|
BLAST will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
大体时间：every two months over six months
|
Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
TAP will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
BLAST will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
大体时间：every two months over six months
|
ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
大体时间：every two months over six months
|
TAP will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
大体时间：every two months over six months
|
BLAST will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
大体时间：every two months over six months
|
Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
ADHD Rating Scale (questions with odd numbers)will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
TAP will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
BLAST will be evaluated ADHD children of groups A, B and C will be compared
|
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.
大体时间：every two months over six months
|
Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
|
every two months over six months
|
|
Evaluate the impact of the trainings on the sleep quality in ADHD children.
大体时间：every two months over six months.
|
Sleep questionnaires will be distributed ADHD children in groups A, B and C will be compared.
|
every two months over six months.
|
|
Evaluate the impact of the trainings on the sleep quality in ADHD children.
大体时间：every two months over six months.
|
The sleep data may also be collected using an actigraph (ancillary study).
ADHD children in groups A, B and C will be compared.
|
every two months over six months.
|
|
Evaluating the impact of the trainings on the quality of life in ADHD children.
大体时间：every two months over six months
|
The Child Behavior CheckList (CBCL) questionnaire will be performed Groups A, B and C will be compared. |
every two months over six months
|
|
Evaluating the impact of the trainings on the quality of life in ADHD children.
大体时间：every two months over six months
|
Information about the quality of life will be also collected in a logbook by family members and provided at each visit. Groups A, B and C will be compared. |
every two months over six months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Alexis ARZIMANOGLOU、Hospices Civils de Lyon
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年2月2日
初级完成 (实际的)
2019年9月9日
研究完成 (实际的)
2019年9月9日
研究注册日期
首次提交
2017年8月4日
首先提交符合 QC 标准的
2017年9月18日
首次发布 (实际的)
2017年9月21日
研究记录更新
最后更新发布 (实际的)
2019年10月29日
上次提交的符合 QC 标准的更新
2019年10月28日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Neurofeedback training的临床试验
-
Karolinska InstitutetMinistry of Health and Social Affairs, Sweden完全的
-
Southern Methodist UniversityKing's College London完全的
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Mental Health Services in the Capital Region, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention Research; Center for Clinical Intervention...完全的