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.
調査の概要
研究の種類
介入
入学 (実際)
52
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Bron、フランス、69500
- Hospices Civils de Lyon
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
8年～17年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
アクティブコンパレータ：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. |
|
アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Alexis ARZIMANOGLOU、Hospices Civils de Lyon
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年2月2日
一次修了 (実際)
2019年9月9日
研究の完了 (実際)
2019年9月9日
試験登録日
最初に提出
2017年8月4日
QC基準を満たした最初の提出物
2017年9月18日
最初の投稿 (実際)
2017年9月21日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月29日
QC基準を満たした最後の更新が送信されました
2019年10月28日
最終確認日
2019年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Neurofeedback trainingの臨床試験
-
Jade Carvalho Da SilvaSantos Dumont Instituteまだ募集していません
-
Trustees of Princeton UniversityNational Institute of Mental Health (NIMH)募集
-
University of Electronic Science and Technology...募集
-
University of MinnesotaNational Institute of Mental Health (NIMH)完了精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
-
VA Office of Research and Development募集
-
University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了