NEUROFEEDBACK on Event-Related Potential (ERP)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

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.
    


Intervention name(s): Neurofeedback training; Active Sham control; Baseline control group
Intervention type(s): Other; Other; Other
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Attention Deficit Disorder with Hyperactivity; ADHD; Children; Inattention; Hyperactivity; Neurofeedback; Neuropsychology