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CompletedNCT03289793MyBUpdated Oct 29, 2019

NEUROFEEDBACK on Event-Related Potential (ERP)

An interventional study of Neurofeedback training and Active Sham control in Attention Deficit Disorder With Hyperactivity, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-10-29.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
8 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Attention Deficit Disorder With Hyperactivity

Keywords

  • Attention Deficit Disorder with Hyperactivity
  • ADHD
  • Children
  • Inattention
  • Hyperactivity
  • Neurofeedback
  • Neuropsychology
03

Who can participate

Ages eligible
8 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    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.

    Other: Neurofeedback training

  • Active comparator
    Group B

    Children will be assigned in this group in a random fashion. 10 subjects will be included in this group.

    Other: Active Sham control

  • Active comparator
    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.

    Other: Baseline control group

Interventions

  • OtherNeurofeedback 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.

  • OtherActive 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.

  • OtherBaseline 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.

05

What researchers measure

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

    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".

    Time frame: every two months over six months.

Secondary outcomes

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

    ADHD Rating Scale (questions with odd numbers) will be performed ADHD children from groups A, B and C will be compared

    Time frame: every months over six months.

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

    Bron/Lyon Attention Stability test (BLAST) test will be performed ADHD children from groups A, B and C will be compared

    Time frame: every months over six months.

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

    Wechsler Intelligence Scale for Children (WISC) subtests will be performed ADHD children from groups A, B and C will be compared

    Time frame: every months over six months.

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

    Wechsler Intelligence Scale for Children (WISC) will be performed ADHD children from groups A, B and C will be compared

    Time frame: every months over six months.

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

    ADHD Rating Scale (questions with odd numbers) will be performed ADHD children from groups A, B and C will be compared

    Time frame: every months over six months.

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

    Bron/Lyon Attention Stability test (BLAST) will be performed ADHD children from groups A, B and C will be compared

    Time frame: every months over six months.

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

    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

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared

    Time frame: every two months over six months

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

    Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

    Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared

    Time frame: every two months over six months

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

    Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

    Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with odd numbers)will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

    Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

    Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

    Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

    Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

    Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

    Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

    Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

    ADHD Rating Scale (questions with odd numbers)will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months

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

    Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared

    Time frame: every two months over six months

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

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

    Time frame: every two months over six months.

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

    The sleep data may also be collected using an actigraph (ancillary study). ADHD children in groups A, B and C will be compared.

    Time frame: every two months over six months.

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

    The Child Behavior CheckList (CBCL) questionnaire will be performed Groups A, B and C will be compared.

    Time frame: every two months over six months

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

    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.

    Time frame: every two months over six months

06

Study locations

1 site
  • Hospices Civils de Lyon
    Bron, 69500, France
07

Registry details

Key details

Study ID
NCT03289793
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Feb 2, 2017
Primary completion
Sep 9, 2019
Completion
Sep 9, 2019
Last update
Oct 29, 2019

Study contacts

Alexis ARZIMANOGLOU
principal investigator · Hospices Civils de Lyon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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