Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03972761
Status:
UNKNOWN
Last Update Posted:
2019-06-04
First Post:
2019-05-31
Brief Title:
Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
NOT_YET_RECRUITING
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:
EPIREM
Brief Summary:
Infantile brain plasticity is still a poorly known phenomenon However neuropsychological disorders and behavioral deficits are common disorders that can have serious consequences for school enrollment family and social adjustment as well as repercussions on future adult lives
In addition generally very premature infants TGP have identifiable executive function disorders EF particularly those involving attentional processes such as working memory WM
The main objective of the study is to evaluate the effects of cognitive remediation CR strategies on the brain plasticity of the cortical areas involved in the management of WM in school-aged TGP children 8 years
The secondary objective of the study is to evaluate the action of CR on the development of cortical areas concerned
It is a monocentric prospective and comparative study of the exposed type to cognitive remediation - unexposed Recruitment and data collection are carried out prospectively in connection with the original study EPIREMED Included patients will be explored by Magnetic Resonance Imaging MRI 3 resting state Tesla
The main hypothesis is that CR strategies have a beneficial effect on the cognitive processing of visual-spatial executive functions but also on the cortical areas involved in brain plasticity in general indirect benefits not to mention the psychological benefits ad hoc to such studies self-esteem increased concentration new stress management strategies put in place
The ultimate objective of this study is to better understand the mechanisms of cerebral plasticity concerning higher executive functions Moreover this study should make it possible to confirm the improvement of the overall fate of the child by better understanding the neuropsychological and anatomical origins of his disorders Interventions taking into account the environment of the very premature baby are necessary because it is closely linked to the developmental future
In addition generally very premature infants TGP have identifiable executive function disorders EF particularly those involving attentional processes such as working memory WM
The main objective of the study is to evaluate the effects of cognitive remediation CR strategies on the brain plasticity of the cortical areas involved in the management of WM in school-aged TGP children 8 years
The secondary objective of the study is to evaluate the action of CR on the development of cortical areas concerned
It is a monocentric prospective and comparative study of the exposed type to cognitive remediation - unexposed Recruitment and data collection are carried out prospectively in connection with the original study EPIREMED Included patients will be explored by Magnetic Resonance Imaging MRI 3 resting state Tesla
The main hypothesis is that CR strategies have a beneficial effect on the cognitive processing of visual-spatial executive functions but also on the cortical areas involved in brain plasticity in general indirect benefits not to mention the psychological benefits ad hoc to such studies self-esteem increased concentration new stress management strategies put in place
The ultimate objective of this study is to better understand the mechanisms of cerebral plasticity concerning higher executive functions Moreover this study should make it possible to confirm the improvement of the overall fate of the child by better understanding the neuropsychological and anatomical origins of his disorders Interventions taking into account the environment of the very premature baby are necessary because it is closely linked to the developmental future
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RCAPHM19_0023 | OTHER | Secondary AP-HM number | None |
| 2019-A00829-48 | OTHER | None | None |