<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03289793</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL15_0214</org_study_id>
    <nct_id>NCT03289793</nct_id>
  </id_info>
  <brief_title>NEUROFEEDBACK on Event-Related Potential (ERP)</brief_title>
  <acronym>MyB</acronym>
  <official_title>Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project aims to assess the evolution of symptoms in ADHD children from 8 to 17 years,&#xD;
      with various types of attention training.&#xD;
&#xD;
      Different groups A, B and C will be evaluated: the first with Neurofeedback training, the&#xD;
      second with a similar training but not indexed on brain activity and the third without&#xD;
      training.&#xD;
&#xD;
      30 patients will be randomly assigned to groups A and B according to a ratio 2:1.&#xD;
&#xD;
      Others patients who meet the same criteria but for logistical reasons cannot comply with the&#xD;
      training constraints will be assigned to group C.&#xD;
&#xD;
      Children included in groups A and B will participate in training sessions (Neurofeedback and&#xD;
      control training, respectively) as well as in four evaluation sessions. Children in group C&#xD;
      will only participate in evaluation sessions (baseline control group).&#xD;
&#xD;
      Patients of groups A and B will be followed over 6 months: 4 months of training and a&#xD;
      follow-up evaluation 2 months after training.&#xD;
&#xD;
      Patients of group C will be followed each 2 months for 6 months. This study uses&#xD;
      electro-encephalography measures, serious video game, neuropsychological tests and&#xD;
      questionnaires.&#xD;
&#xD;
      It also uses actigraphy measures to evaluate sleep quality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">September 9, 2019</completion_date>
  <primary_completion_date type="Actual">September 9, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>every two months over six months.</time_frame>
    <description>Questions with odd numbers interested in the dimension &quot;inattentive&quot; 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 &quot; 2=Often; 3=Very often&quot; to &quot; 1=Sometimes; 0=Rarely/Never&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children</measure>
    <time_frame>every months over six months.</time_frame>
    <description>ADHD Rating Scale (questions with odd numbers) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children</measure>
    <time_frame>every months over six months.</time_frame>
    <description>Bron/Lyon Attention Stability test (BLAST) test will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children</measure>
    <time_frame>every months over six months.</time_frame>
    <description>Wechsler Intelligence Scale for Children (WISC) subtests will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children</measure>
    <time_frame>every months over six months.</time_frame>
    <description>Wechsler Intelligence Scale for Children (WISC) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children</measure>
    <time_frame>every months over six months.</time_frame>
    <description>ADHD Rating Scale (questions with odd numbers) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children</measure>
    <time_frame>every months over six months.</time_frame>
    <description>Bron/Lyon Attention Stability test (BLAST) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the effects of the two types of trainings on the hyperactivity symptoms in ADHD children using neuropsychological assessments.</measure>
    <time_frame>every two months over six months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>TAP will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>CPT will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>BLAST will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with odd numbers)will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>TAP will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>CPT will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>BLAST will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>TAP will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>CPT will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>BLAST will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))</measure>
    <time_frame>every two months over six months</time_frame>
    <description>TAP will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))</measure>
    <time_frame>every two months over six months</time_frame>
    <description>BLAST will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>TAP will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>BLAST will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)</measure>
    <time_frame>every two months over six months</time_frame>
    <description>TAP will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)</measure>
    <time_frame>every two months over six months</time_frame>
    <description>BLAST will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>TAP will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>BLAST will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)</measure>
    <time_frame>every two months over six months</time_frame>
    <description>TAP will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)</measure>
    <time_frame>every two months over six months</time_frame>
    <description>BLAST will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>ADHD Rating Scale (questions with odd numbers)will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>TAP will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>BLAST will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the impact of the trainings on the sleep quality in ADHD children.</measure>
    <time_frame>every two months over six months.</time_frame>
    <description>Sleep questionnaires will be distributed ADHD children in groups A, B and C will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the impact of the trainings on the sleep quality in ADHD children.</measure>
    <time_frame>every two months over six months.</time_frame>
    <description>The sleep data may also be collected using an actigraph (ancillary study). ADHD children in groups A, B and C will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating the impact of the trainings on the quality of life in ADHD children.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>The Child Behavior CheckList (CBCL) questionnaire will be performed&#xD;
Groups A, B and C will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating the impact of the trainings on the quality of life in ADHD children.</measure>
    <time_frame>every two months over six months</time_frame>
    <description>Information about the quality of life will be also collected in a logbook by family members and provided at each visit.&#xD;
Groups A, B and C will be compared.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Attention Deficit Disorder With Hyperactivity</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).&#xD;
20 subjects will be included in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Children will be assigned in this group in a random fashion. 10 subjects will be included in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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).&#xD;
Group C allows to follow the natural evolution of children with ADHD with no intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurofeedback training</intervention_name>
    <description>Children in group A will receive BCI-based training implemented through original P300-based controlled games.&#xD;
They will attend 30 1-hour long training sessions at a pace of 2 sessions per week.&#xD;
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.&#xD;
Moreover, 4 neuropsychological sessions will complement the 30 training sessions. During these sessions neuropsychological tests and quality of life questionnaires will be answered.</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active Sham control</intervention_name>
    <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.&#xD;
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.&#xD;
Besides, 4 neuropsychological sessions will complement the 30 training sessions. During these sessions neuropsychological tests and quality of life questionnaires will be performed.</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Baseline control group</intervention_name>
    <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.</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children and teenagers aged from 8 to 17 years' old&#xD;
&#xD;
          -  Children and teenagers with a deficit attention disorder with or without&#xD;
             hyperactivity, in the mixed form or in a pure inattentive form according to&#xD;
             Diagnostique et Statistique des troubles Mentaux (DSM)-V.&#xD;
&#xD;
          -  Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal&#xD;
             Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) ≥ 80 of WISC IV&#xD;
             or V test, not older than two years.&#xD;
&#xD;
          -  Children and teenagers without psychostimulant treatment&#xD;
&#xD;
          -  Children and teenagers with psychostimulant treatment agreed to achieve a therapeutic&#xD;
             break at each visit day and with a stable dose during all the study.&#xD;
&#xD;
          -  Children and teenagers whose parents have agreed and signed informed consent form of&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children aged less than 8 and teenagers are more than 18 years' old.&#xD;
&#xD;
          -  Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal&#xD;
             Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) &lt; 80 of WISC IV&#xD;
             or V test, not older than two years.&#xD;
&#xD;
          -  Children and teenagers with developmental disorder except &quot;Dys&quot; disorders.&#xD;
&#xD;
          -  Children and teenagers with pure hyperactivity (without attentional deficit)&#xD;
&#xD;
          -  Children and teenagers with epilepsy except benign epilepsies (without brain damage),&#xD;
             free of crisis for two years and without treatment.&#xD;
&#xD;
          -  Children and teenagers with ADHD with conduct disorders and aggression&#xD;
&#xD;
          -  Children and teenagers with ADHD and Tourette's syndrome.&#xD;
&#xD;
          -  Patients treated by anti / epilepsy or psychotropic treatments (with the exception of&#xD;
             psychostimulant treatment).&#xD;
&#xD;
          -  Patients with psychostimulant treatment and whose parents aren't agreed to achieve a&#xD;
             therapeutic break at each visit day.&#xD;
&#xD;
          -  Patients with visual deficiency uncorrectable with lenses or glasses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexis ARZIMANOGLOU</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>October 28, 2019</last_update_submitted>
  <last_update_submitted_qc>October 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Attention Deficit Disorder with Hyperactivity</keyword>
  <keyword>ADHD</keyword>
  <keyword>Children</keyword>
  <keyword>Inattention</keyword>
  <keyword>Hyperactivity</keyword>
  <keyword>Neurofeedback</keyword>
  <keyword>Neuropsychology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03289793
org study id: 69HCL15_0214
nct id: NCT03289793
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Investigator)
measure: 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.
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".
measure: Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
time frame: every months over six months.
description: ADHD Rating Scale (questions with odd numbers) will be performed ADHD children from groups A, B and C will be compared
measure: Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
time frame: every months over six months.
description: Bron/Lyon Attention Stability test (BLAST) test will be performed ADHD children from groups A, B and C will be compared
measure: Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
time frame: every months over six months.
description: Wechsler Intelligence Scale for Children (WISC) subtests will be performed ADHD children from groups A, B and C will be compared
measure: 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.
description: Wechsler Intelligence Scale for Children (WISC) will be performed ADHD children from groups A, B and C will be compared
measure: 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.
description: ADHD Rating Scale (questions with odd numbers) will be performed ADHD children from groups A, B and C will be compared
measure: 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.
description: Bron/Lyon Attention Stability test (BLAST) will be performed ADHD children from groups A, B and C will be compared
measure: 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
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
measure: 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
description: ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared
measure: 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
description: Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared
measure: 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
description: Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared
measure: 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
description: Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared
measure: 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
description: Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared
measure: 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
description: ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared
measure: 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
description: Continuous Performance Test (CPT) will be performed ADHD children from groups A, B and C will be compared
measure: 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
description: ADHD Rating Scale (questions with even numbers) will be performed ADHD children from groups A, B and C will be compared
measure: 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
description: Test d'évaluation de l'Attention (TAP) will be performed ADHD children from groups A, B and C will be compared
measure: 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
description: ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: TAP will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: CPT will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: BLAST will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: ADHD Rating Scale (questions with odd numbers)will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: TAP will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: CPT will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: BLAST will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: TAP will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: CPT will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: BLAST will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: Attention and Distractibility Questionnaire (for children) will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
time frame: every two months over six months
description: ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
time frame: every two months over six months
description: TAP will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
time frame: every two months over six months
description: BLAST will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
time frame: every two months over six months
description: Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: TAP will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: BLAST will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
time frame: every two months over six months
description: ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
time frame: every two months over six months
description: TAP will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
time frame: every two months over six months
description: BLAST will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
time frame: every two months over six months
description: Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: TAP will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: BLAST will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
time frame: every two months over six months
description: ADHD Rating Scale (questions with odd numbers) will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
time frame: every two months over six months
description: TAP will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
time frame: every two months over six months
description: BLAST will be evaluated ADHD children of groups A, B and C will be compared
measure: Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
time frame: every two months over six months
description: Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: ADHD Rating Scale (questions with odd numbers)will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: TAP will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: BLAST will be evaluated ADHD children of groups A, B and C will be compared
measure: 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
description: Attention and Distractibility Questionnaire (child) will be evaluated ADHD children of groups A, B and C will be compared
measure: Evaluate the impact of the trainings on the sleep quality in ADHD children.
time frame: every two months over six months.
description: Sleep questionnaires will be distributed ADHD children in groups A, B and C will be compared.
measure: Evaluate the impact of the trainings on the sleep quality in ADHD children.
time frame: every two months over six months.
description: The sleep data may also be collected using an actigraph (ancillary study). ADHD children in groups A, B and C will be compared.
measure: Evaluating the impact of the trainings on the quality of life in ADHD children.
time frame: every two months over six months
description: The Child Behavior CheckList (CBCL) questionnaire will be performed
Groups A, B and C will be compared.
measure: Evaluating the impact of the trainings on the quality of life in ADHD children.
time frame: every two months over six months
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.
arm group label: Group A
arm group type: Experimental
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 group label: Group B
arm group type: Active Comparator
description: Children will be assigned in this group in a random fashion. 10 subjects will be included in this group.
arm group label: Group C
arm group type: Active Comparator
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: Neurofeedback training
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.
arm group label: Group A
intervention type: Other
intervention name: Active Sham control
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.
arm group label: Group B
intervention type: Other
intervention name: Baseline control group
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.
arm group label: Group C
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Alexis ARZIMANOGLOU
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity