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Completed

NCT Number: NCT03289793

NEUROFEEDBACK on Event-Related Potential (ERP)

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurofeedback training

Other

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.

Active Sham control

Other

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.

Baseline control group

Other

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.

Primary outcomes

  1. 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

    Time frame: 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".

Secondary outcomes

  1. Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children

    Time frame: 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

  2. Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children

    Time frame: 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

  3. Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children

    Time frame: 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

  4. Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children

    Time frame: 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

  5. Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children

    Time frame: 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

  6. Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children

    Time frame: 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

  7. Compare the effects of the two types of trainings on the hyperactivity symptoms in ADHD children using neuropsychological assessments.

    Time frame: 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

  8. neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children

    Time frame: 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

  9. neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children

    Time frame: 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

  10. neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children

    Time frame: every two months over six months

    Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared

  11. neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children

    Time frame: every two months over six months

    Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared

  12. neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children

    Time frame: 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

  13. neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children

    Time frame: 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

  14. neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children

    Time frame: every two months over six months

    Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared

  15. neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children

    Time frame: 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

  16. neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children

    Time frame: 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

  17. Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: 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

  18. Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: every two months over six months

    TAP will be evaluated ADHD children of groups A, B and C will be compared

  19. Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: every two months over six months

    CPT will be evaluated ADHD children of groups A, B and C will be compared

  20. Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: every two months over six months

    BLAST will be evaluated ADHD children of groups A, B and C will be compared

  21. Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: 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

  22. Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: 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

  23. Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: every two months over six months

    TAP will be evaluated ADHD children of groups A, B and C will be compared

  24. Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: every two months over six months

    CPT will be evaluated ADHD children of groups A, B and C will be compared

  25. Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: every two months over six months

    BLAST will be evaluated ADHD children of groups A, B and C will be compared

  26. Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: 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

  27. Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: 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

  28. Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: every two months over six months

    TAP will be evaluated ADHD children of groups A, B and C will be compared

  29. Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: every two months over six months

    CPT will be evaluated ADHD children of groups A, B and C will be compared

  30. Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: every two months over six months

    BLAST will be evaluated ADHD children of groups A, B and C will be compared

  31. Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.

    Time frame: 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

  32. Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))

    Time frame: 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

  33. Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))

    Time frame: every two months over six months

    TAP will be evaluated ADHD children of groups A, B and C will be compared

  34. Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))

    Time frame: every two months over six months

    BLAST will be evaluated ADHD children of groups A, B and C will be compared

  35. Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))

    Time frame: 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

  36. Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: 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

  37. Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: every two months over six months

    TAP will be evaluated ADHD children of groups A, B and C will be compared

  38. Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: every two months over six months

    BLAST will be evaluated ADHD children of groups A, B and C will be compared

  39. Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: 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

  40. Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)

    Time frame: 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

  41. Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)

    Time frame: every two months over six months

    TAP will be evaluated ADHD children of groups A, B and C will be compared

  42. Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)

    Time frame: every two months over six months

    BLAST will be evaluated ADHD children of groups A, B and C will be compared

  43. Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)

    Time frame: 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

  44. Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: 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

  45. Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: every two months over six months

    TAP will be evaluated ADHD children of groups A, B and C will be compared

  46. Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: every two months over six months

    BLAST will be evaluated ADHD children of groups A, B and C will be compared

  47. Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: 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

  48. Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)

    Time frame: 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

  49. Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)

    Time frame: every two months over six months

    TAP will be evaluated ADHD children of groups A, B and C will be compared

  50. Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)

    Time frame: every two months over six months

    BLAST will be evaluated ADHD children of groups A, B and C will be compared

  51. Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)

    Time frame: 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

  52. Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: 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

  53. Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: every two months over six months

    TAP will be evaluated ADHD children of groups A, B and C will be compared

  54. Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: every two months over six months

    BLAST will be evaluated ADHD children of groups A, B and C will be compared

  55. Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.

    Time frame: 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

  56. Evaluate the impact of the trainings on the sleep quality in ADHD children.

    Time frame: every two months over six months.

    Sleep questionnaires will be distributed ADHD children in groups A, B and C will be compared.

  57. Evaluate the impact of the trainings on the sleep quality in ADHD children.

    Time frame: 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.

  58. Evaluating the impact of the trainings on the quality of life in ADHD children.

    Time frame: every two months over six months

    The Child Behavior CheckList (CBCL) questionnaire will be performed

    Groups A, B and C will be compared.

  59. Evaluating the impact of the trainings on the quality of life in ADHD children.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Acronym: MyB

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 21, 2017
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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