Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2017-02-02
2019-09-09
Brief Summary
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Different groups A, B and C will be evaluated: the first with Neurofeedback training, the second with a similar training but not indexed on brain activity and the third without training.
30 patients will be randomly assigned to groups A and B according to a ratio 2:1.
Others patients who meet the same criteria but for logistical reasons cannot comply with the training constraints will be assigned to group C.
Children included in groups A and B will participate in training sessions (Neurofeedback and control training, respectively) as well as in four evaluation sessions. Children in group C will only participate in evaluation sessions (baseline control group).
Patients of groups A and B will be followed over 6 months: 4 months of training and a follow-up evaluation 2 months after training.
Patients of group C will be followed each 2 months for 6 months. This study uses electro-encephalography measures, serious video game, neuropsychological tests and questionnaires.
It also uses actigraphy measures to evaluate sleep quality.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Group A
Children will be assigned to this group in a random fashion according to a ratio 2:1 with respect to group B (see below).
20 subjects will be included in this group.
Neurofeedback training
Children in group A will receive BCI-based training implemented through original P300-based controlled games.
They will attend 30 1-hour long training sessions at a pace of 2 sessions per week.
Each session includes: installation of the child, the EEG system and an eye-tracking system, a 5-minutes relaxation phase, a short EEG recording at rest, a brief reminder of the instructions, 30 minutes of training by playing video games and finally a time for the child to wash her/his hair.
Moreover, 4 neuropsychological sessions will complement the 30 training sessions. During these sessions neuropsychological tests and quality of life questionnaires will be answered.
Group B
Children will be assigned in this group in a random fashion. 10 subjects will be included in this group.
Active Sham control
Children in group B will receive a training that is not based on brain activity, but in a blind fashion. They will attend 30 1-hour long training sessions at a pace of 2 sessions per week.
Each session includes: installation of the child, setting up the EEG and eye-tracking systems, a 5-minutes relaxation phase, short EEG recording at rest, a brief reminder of the instructions, 30 minutes of video game based training and finally a time for the child to wash her/his hair.
Besides, 4 neuropsychological sessions will complement the 30 training sessions. During these sessions neuropsychological tests and quality of life questionnaires will be performed.
Group C
Will be included in this group children who meet the inclusion criteria and who, with their families, are motivated to participate in the study but cannot claim to be part of groups A or B (because of logistical constraints: living too far away to comply with the frequency of the visits required by the training).
Group C allows to follow the natural evolution of children with ADHD with no intervention.
Baseline control group
The children included in this group will not receive any training. They only take part to the 4 neuropsychological sessions. Like others, they will attend 1 neuropsychological session every two months over six months.
Interventions
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Neurofeedback training
Children in group A will receive BCI-based training implemented through original P300-based controlled games.
They will attend 30 1-hour long training sessions at a pace of 2 sessions per week.
Each session includes: installation of the child, the EEG system and an eye-tracking system, a 5-minutes relaxation phase, a short EEG recording at rest, a brief reminder of the instructions, 30 minutes of training by playing video games and finally a time for the child to wash her/his hair.
Moreover, 4 neuropsychological sessions will complement the 30 training sessions. During these sessions neuropsychological tests and quality of life questionnaires will be answered.
Active Sham control
Children in group B will receive a training that is not based on brain activity, but in a blind fashion. They will attend 30 1-hour long training sessions at a pace of 2 sessions per week.
Each session includes: installation of the child, setting up the EEG and eye-tracking systems, a 5-minutes relaxation phase, short EEG recording at rest, a brief reminder of the instructions, 30 minutes of video game based training and finally a time for the child to wash her/his hair.
Besides, 4 neuropsychological sessions will complement the 30 training sessions. During these sessions neuropsychological tests and quality of life questionnaires will be performed.
Baseline control group
The children included in this group will not receive any training. They only take part to the 4 neuropsychological sessions. Like others, they will attend 1 neuropsychological session every two months over six months.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
8 Years
17 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Alexis ARZIMANOGLOU
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hospices Civils de Lyon
Bron, , France
Countries
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Other Identifiers
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69HCL15_0214
Identifier Type: -
Identifier Source: org_study_id
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