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NEUROFEEDBACK on Event-Related Potential (ERP) (MyB)

28. října 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

52

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Francie
      • Bron, Francie, 69500
        • Hospices Civils de Lyon

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

8 let až 17 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: Neurofeedback training

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.
Aktivní komparátor: Group B
Children will be assigned in this group in a random fashion. 10 subjects will be included in this group.
Jiný: Active Sham control

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.
Aktivní komparátor: 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.
Jiný: Baseline control group
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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))
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hospices Civils de Lyon

Vyšetřovatelé

  • Vrchní vyšetřovatel: Alexis ARZIMANOGLOU, Hospices Civils de Lyon

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

2. února 2017

Primární dokončení (Aktuální)

9. září 2019

Dokončení studie (Aktuální)

9. září 2019

Termíny zápisu do studia

První předloženo

4. srpna 2017

První předloženo, které splnilo kritéria kontroly kvality

18. září 2017

První zveřejněno (Aktuální)

21. září 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. října 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. října 2019

Naposledy ověřeno

1. října 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 69HCL15_0214

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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