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Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation

NCT03972761 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-06-04

No results posted yet for this study

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.

Conditions

  • Premature Childbirth

Interventions

DEVICE

Magnetic Resonance Imaging (MRI) 3 tesla

Functional neuroimaging objectifies the activation of specific areas of the brain

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Jean-Olivier ARNAUD, Director · Assistance Publique Hôpitaux de Marseille

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2021-09-26
Completion
2021-09-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03972761 on ClinicalTrials.gov