Clinical trial NCT03289793: NEUROFEEDBACK on Event-Related Potential (ERP)
Official title: Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Disorder with Hyperactivity
ADHD
Children
Inattention
Hyperactivity
Neurofeedback
Neuropsychology
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 52
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project aims to assess the evolution of symptoms in ADHD children from 8 to 17 years, with various types of attention training.

Different groups A, B and C will be evaluated: the first with Neurofeedback training, the second with a similar training but not indexed on brain activity and the third without training.

30 patients will be randomly assigned to groups A and B according to a ratio 2:1.

Others patients who meet the same criteria but for logistical reasons cannot comply with the training constraints will be assigned to group C.

Children included in groups A and B will participate in training sessions (Neurofeedback and control training, respectively) as well as in four evaluation sessions. Children in group C will only participate in evaluation sessions (baseline control group).

Patients of groups A and B will be followed over 6 months: 4 months of training and a follow-up evaluation 2 months after training.

Patients of group C will be followed each 2 months for 6 months. This study uses electro-encephalography measures, serious video game, neuropsychological tests and questionnaires.

It also uses actigraphy measures to evaluate sleep quality.


Eligibility criteria: Inclusion Criteria:

* Children and teenagers aged from 8 to 17 years' old
* Children and teenagers with a deficit attention disorder with or without hyperactivity, in the mixed form or in a pure inattentive form according to Diagnostique et Statistique des troubles Mentaux (DSM)-V.
* Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) ≥ 80 of WISC IV or V test, not older than two years.
* Children and teenagers without psychostimulant treatment
* Children and teenagers with psychostimulant treatment agreed to achieve a therapeutic break at each visit day and with a stable dose during all the study.
* Children and teenagers whose parents have agreed and signed informed consent form of the study.

Exclusion Criteria:

* Children aged less than 8 and teenagers are more than 18 years' old.
* Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) \< 80 of WISC IV or V test, not older than two years.
* Children and teenagers with developmental disorder except "Dys" disorders.
* Children and teenagers with pure hyperactivity (without attentional deficit)
* Children and teenagers with epilepsy except benign epilepsies (without brain damage), free of crisis for two years and without treatment.
* Children and teenagers with ADHD with conduct disorders and aggression
* Children and teenagers with ADHD and Tourette's syndrome.
* Patients treated by anti / epilepsy or psychotropic treatments (with the exception of psychostimulant treatment).
* Patients with psychostimulant treatment and whose parents aren't agreed to achieve a therapeutic break at each visit day.
* Patients with visual deficiency uncorrectable with lenses or glasses.

Primary outcomes:
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
timeFrame: every two months over six months.
Secondary outcomes:
measure: Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
timeFrame: every months over six months.
measure: Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
timeFrame: every months over six months.
measure: Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children
timeFrame: every months over six months.
measure: Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children
timeFrame: every months over six months.
measure: Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children
timeFrame: every months over six months.
measure: Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children
timeFrame: every months over six months.
measure: Compare the effects of the two types of trainings on the hyperactivity symptoms in ADHD children using neuropsychological assessments.
timeFrame: every two months over six months
measure: neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children
timeFrame: every two months over six months
measure: neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children
timeFrame: every two months over six months
measure: neuropsychological assessments of the effects of the two types of trainings on the hyperactivity symptoms in ADHD children
timeFrame: every two months over six months
measure: neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children
timeFrame: every two months over six months
measure: neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children
timeFrame: every two months over six months
measure: neuropsychological assessments of the effects of the lack of training on the impulsivity symptoms in ADHD children
timeFrame: every two months over six months
measure: neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children
timeFrame: every two months over six months
measure: neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children
timeFrame: every two months over six months
measure: neuropsychological assessments of the effects of the lack of training on the hyperactivity symptoms in ADHD children
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups A (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups B (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify whether the changes in inattentive symptoms in groups C (Neurofeedback training) correlate with changes in specific EEG parameter, namely the P300 wave.
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Slow Cortical Potential (SCP))
timeFrame: every two months over six months
measure: Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Assess whether the classical Neurofeedback biomarkers correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Theta/Beta Ratio (TBR)
timeFrame: every two months over six months
measure: Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Assess whether the classical Neurofeedback biomarkers TBR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
timeFrame: every two months over six months
measure: Quantify the evolution of the classical Neurofeedback biomarkers Sensori-Moteur Rythm (SMR)
timeFrame: every two months over six months
measure: Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Assess whether the Neurofeedback biomarkers SMR correlate with the evolution of behavioral and primary neurophysiological measures (P300) in all groups.
timeFrame: every two months over six months
measure: Evaluate the impact of the trainings on the sleep quality in ADHD children.
timeFrame: every two months over six months.
measure: Evaluate the impact of the trainings on the sleep quality in ADHD children.
timeFrame: every two months over six months.
measure: Evaluating the impact of the trainings on the quality of life in ADHD children.
timeFrame: every two months over six months
measure: Evaluating the impact of the trainings on the quality of life in ADHD children.
timeFrame: every two months over six months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Alexis ARZIMANOGLOU
role: PRINCIPAL_INVESTIGATOR
References: