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

28 ottobre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

52

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 8 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Comparatore attivo: Group B
Children will be assigned in this group in a random fashion. 10 subjects will be included in this group.
Altro: 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.
Comparatore attivo: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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))
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospices Civils de Lyon

Investigatori

  • Investigatore principale: Alexis ARZIMANOGLOU, Hospices Civils de Lyon

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 febbraio 2017

Completamento primario (Effettivo)

9 settembre 2019

Completamento dello studio (Effettivo)

9 settembre 2019

Date di iscrizione allo studio

Primo inviato

4 agosto 2017

Primo inviato che soddisfa i criteri di controllo qualità

18 settembre 2017

Primo Inserito (Effettivo)

21 settembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 ottobre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2019

Ultimo verificato

1 ottobre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 69HCL15_0214

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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