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

28. oktober 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

52

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

8 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Aktiv komparator: Group B
Children will be assigned in this group in a random fashion. 10 subjects will be included in this group.
Annen: 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.
Aktiv komparator: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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))
Tidsramme: 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))
Tidsramme: 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))
Tidsramme: 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))
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospices Civils de Lyon

Etterforskere

  • Hovedetterforsker: Alexis ARZIMANOGLOU, Hospices Civils de Lyon

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. februar 2017

Primær fullføring (Faktiske)

9. september 2019

Studiet fullført (Faktiske)

9. september 2019

Datoer for studieregistrering

Først innsendt

4. august 2017

Først innsendt som oppfylte QC-kriteriene

18. september 2017

Først lagt ut (Faktiske)

21. september 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 69HCL15_0214

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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