Attention Deficit Disorder With HyperactivityMyBNCT03289793
NEUROFEEDBACK on Event-Related Potential (ERP)
A study testing Neurofeedback training in people with Attention Deficit Disorder With Hyperactivity, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Neurofeedback training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2017to 9 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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.
Read more
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.
- Being tested
- Neurofeedback training, Active Sham control, Baseline control group
- Keywords
- Attention Deficit Disorder with Hyperactivity, ADHD, Children, Inattention, Hyperactivity, Neurofeedback, Neuropsychology
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback trainingOther
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 controlOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Other: Neurofeedback training |
| Group B | Active comparator | Children will be assigned in this group in a random fashion. 10 subjects will be included in this group. Receives: Other: Active Sham control |
| Group C | Active comparator | 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. Receives: Other: Baseline control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: every two months over six months.
Secondary outcomes (59)
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
Measured: every months over six months.
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
Measured: every months over six months.
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
Measured: every months over six months.
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
Measured: every months over six months.
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
Measured: every months over six months.
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
Measured: every months over six months.
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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
Measured: every two months over six months
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.
Measured: every two months over six months.
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.
Measured: every two months over six months.
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.
Measured: every two months over six months
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.
Measured: every two months over six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start2 Feb 2017
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis ARZIMANOGLOU, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289793
- Sponsor's protocol ID
- 69HCL15_0214
- Acronym
- MyB
- Status last verified
- Oct 2019
- First submitted
- 4 Aug 2017
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT03289793
- Acronym / sponsor ID
- MyB / 69HCL15_0214
- Keywords
- Attention Deficit Disorder with Hyperactivity, ADHD, Children, Inattention, Hyperactivity, Neurofeedback, Neuropsychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Neurofeedback trainingChildren 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. |
| Group B | Active comparator | Other: Active Sham controlChildren will be assigned in this group in a random fashion. 10 subjects will be included in this group. |
| Group C | Active comparator | Other: Baseline control groupWill 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback trainingChildren 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. | Other | Group A |
| Active Sham controlChildren 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. | Other | Group B |
| Baseline control groupThe 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. | Other | Group C |
Primary outcome
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.
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".
59 secondary outcomes
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
Time frame: every months over six months.
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
Time frame: every months over six months.
Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
Time frame: every months over six months.
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.
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
Time frame: every two months over six months
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
Time frame: every two months over six months
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
Time frame: every two months over six months
Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
Time frame: every two months over six months
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
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
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
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
Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
Time frame: every two months over six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis ARZIMANOGLOU principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback training in people with Attention Deficit Disorder With Hyperactivity, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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 (time frame: every two months over six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.