Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation
NCT ID: NCT03972761
Last Updated: 2019-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2019-09-27
2021-09-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group exposed to cognitive remediation
Computerized cognitive remediation program. Program performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)
Magnetic Resonance Imaging (MRI) 3 tesla
Functional neuroimaging objectifies the activation of specific areas of the brain
Group not exposed to cognitive remediation
Standard remediation performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)
Magnetic Resonance Imaging (MRI) 3 tesla
Functional neuroimaging objectifies the activation of specific areas of the brain
Interventions
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Magnetic Resonance Imaging (MRI) 3 tesla
Functional neuroimaging objectifies the activation of specific areas of the brain
Eligibility Criteria
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Inclusion Criteria
* Possessing an intelligence quotient (IQ) greater than 70
Exclusion Criteria
* Child who did not have all the interventions in the EPIREMED study
8 Years
9 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Jean-Olivier ARNAUD, Director
Role: STUDY_DIRECTOR
Assistance Publique Hôpitaux de Marseille
Locations
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Assistance Publique Hôpitaux de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-A00829-48
Identifier Type: OTHER
Identifier Source: secondary_id
RCAPHM19_0023
Identifier Type: OTHER
Identifier Source: secondary_id
2019-07
Identifier Type: -
Identifier Source: org_study_id
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