Ignite Creation Date:
2024-05-06 @ 10:32 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03289793
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2017-08-04
Brief Title:
NEUROFEEDBACK on Event-Related Potential ERP
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Clinical Evaluation of a Brain Computer Interfaces BCI-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder ADHD
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MyB
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 21
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
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 21
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None