Back to resultsNEUROFEEDBACK on Event-Related Potential (ERP) (MyB)
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neurofeedback training
Active Sham control
Baseline control group
Sponsored by
About this trial
This is an interventional health services research trial for Attention Deficit Disorder With Hyperactivity focused on measuring Attention Deficit Disorder with Hyperactivity, ADHD, Children, Inattention, Hyperactivity, Neurofeedback, Neuropsychology
Eligibility Criteria
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.
Sites / Locations
- Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
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.
Children will be assigned in this group in a random fashion. 10 subjects will be included in this group.
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.
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
Full Information
NCT ID
NCT03289793
First Posted
August 4, 2017
Last Updated
October 28, 2019
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03289793
Brief Title
NEUROFEEDBACK on Event-Related Potential (ERP)
Acronym
MyB
Official Title
Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
September 9, 2019 (Actual)
Study Completion Date
September 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Attention Deficit Disorder with Hyperactivity, ADHD, Children, Inattention, Hyperactivity, Neurofeedback, Neuropsychology
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Children will be assigned in this group in a random fashion. 10 subjects will be included in this group.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neurofeedback training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Active Sham control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Baseline control group
Intervention Description
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 Outcome Measure Information:
Title
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
Description
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 Outcome Measure Information:
Title
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
Description
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.
Title
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
Description
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.
Title
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
Description
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.
Title
Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children
Description
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.
Title
Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children
Description
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.
Title
Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children
Description
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.
Title
Compare the effects of the two types of trainings on the hyperactivity symptoms in ADHD children using neuropsychological assessments.
Description
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
Title
neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children
Description
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
Title
neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children
Description
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
Title
neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children
Description
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
Title
neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children
Description
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
Title
neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children
Description
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
Title
neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children
Description
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
Title
neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children
Description
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
Title
neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children
Description
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
Title
neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children
Description
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
Title
Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
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
Title
Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
TAP will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
CPT will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
BLAST will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
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
Title
Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
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
Title
Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
TAP will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
CPT will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
BLAST will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
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
Title
Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
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
Title
Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
TAP will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
CPT will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
BLAST will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
Description
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
Title
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
Description
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
Title
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
Description
TAP will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
Description
BLAST will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
Description
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
Title
Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
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
Title
Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
TAP will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
BLAST will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
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
Title
Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
Description
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
Title
Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
Description
TAP will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
Description
BLAST will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
Description
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
Title
Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
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
Title
Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
TAP will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
BLAST will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
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
Title
Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
Description
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
Title
Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
Description
TAP will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
Description
BLAST will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
Description
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
Title
Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
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
Title
Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
TAP will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
BLAST will be evaluated ADHD children of groups A, B and C will be compared
Time Frame
every two months over six months
Title
Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
Description
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
Title
Evaluate the impact of the trainings on the sleep quality in ADHD children.
Description
Sleep questionnaires will be distributed ADHD children in groups A, B and C will be compared.
Time Frame
every two months over six months.
Title
Evaluate the impact of the trainings on the sleep quality in ADHD children.
Description
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.
Title
Evaluating the impact of the trainings on the quality of life in ADHD children.
Description
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
Title
Evaluating the impact of the trainings on the quality of life in ADHD children.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis ARZIMANOGLOU
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
12. IPD Sharing Statement
Learn more about this trial
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