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

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

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.

Study Overview

• Status: Unknown
• Conditions: Premature Childbirth
• Intervention / Treatment: Device: Magnetic Resonance Imaging (MRI) 3 tesla

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barthélémy TOSELLO, PH; Phone Number: +33 491968300; Email: barthelemy.tosello@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille
    • Contact: Barthélémy TOSELLO, PH; Phone Number: +33 491968300; Email: barthelemy.tosello@ap-hm.fr
    • Principal Investigator: Barthélémy TOSELLO, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group exposed to cognitive remediation; Computerized cognitive remediation program. Program performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)	Device: Magnetic Resonance Imaging (MRI) 3 tesla; Functional neuroimaging objectifies the activation of specific areas of the brain
Placebo Comparator: Group not exposed to cognitive remediation; Standard remediation performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)	Device: Magnetic Resonance Imaging (MRI) 3 tesla; Functional neuroimaging objectifies the activation of specific areas of the brain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activation of cortical areas	Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Anticipated): September 27, 2019
• Primary Completion (Anticipated): September 26, 2021
• Study Completion (Anticipated): September 26, 2021

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2019-07; 2019-A00829-48 (Other Identifier: ID RCB); RCAPHM19_0023 (Other Identifier: Secondary AP-HM number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No