NCT03289793

NEUROFEEDBACK on Event-Related Potential (ERP)

Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2017-02-02
• Primary completion: 2019-09-09
• Completion: 2019-09-09
• First posted: 2017-09-21
• Last updated: 2019-10-29

Locations

1 site across 1 country: France