NEUROFEEDBACK on Event-Related Potential (ERP)

NCT03289793 | Completed

• 1 other identifier: 69HCL15_0214
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Disorder with Hyperactivity; ADHD; Children; Inattention; Hyperactivity; Neurofeedback; Neuropsychology

Outcome Measures

Primary Outcomes (1)

• 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".

  every two months over six months.

Secondary Outcomes (59)

• Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children

  every months over six months.

• Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children

  every months over six months.

• Neuropsychological assessments of effects of training on the symptoms of inattention in ADHD children

  every months over six months.

• Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children

  every months over six months.

• Neuropsychological assessments of the effects of the lack of training on the symptoms of inattention in ADHD children

  every months over six months.

Study Arms (3)

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.

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.

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.

Other: Baseline control group

Interventions

Neurofeedback training OTHER

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 A

Active Sham control OTHER

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 B

Baseline control group OTHER

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.

Group C

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexis ARZIMANOGLOU

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: September 21, 2017
• Study Start: February 2, 2017
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

FR (1)