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

Not Applicable

• Conditions: Premature Childbirth
• Interventions: Device: Magnetic Resonance Imaging (MRI) 3 tesla

• Registration Number: NCT03972761
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Last Update Submitted: 2019-05-31
• Study First Posted: 2019-06-04
• Last Update Posted: 2019-06-04
• Study Start: 2019-09-27
• Primary Completion: 2021-09-26
• Study Completion: 2021-09-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Children born between 24 and 34 weeks of amenorrhea and living in the Provence region
• Possessing an intelligence quotient (IQ) greater than 70

Exclusion Criteria

• Child not understanding French
• Child who did not have all the interventions in the EPIREMED study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group exposed to cognitive remediation	Magnetic Resonance Imaging (MRI) 3 tesla	Computerized cognitive remediation program. Program performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)
Group not exposed to cognitive remediation	Magnetic Resonance Imaging (MRI) 3 tesla	Standard remediation performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)

Primary Outcome Measures

Name	Time	Method
Activation of cortical areas	24 months	Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France