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

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ClinicalTrials.gov Identifier: NCT03972761
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Premature Childbirth Device: Magnetic Resonance Imaging (MRI) 3 tesla Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive
Estimated Study Start Date : September 27, 2019
Estimated Primary Completion Date : September 26, 2021
Estimated Study Completion Date : September 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

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




Primary Outcome Measures :
  1. Activation of cortical areas [ Time Frame: 24 months ]
    Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory



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Ages Eligible for Study:   8 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972761


Contacts
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Contact: Barthélémy TOSELLO, PH 491968300 ext +33 barthelemy.tosello@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: Barthélémy TOSELLO, PH    491968300 ext +33    barthelemy.tosello@ap-hm.fr   
Principal Investigator: Barthélémy TOSELLO, PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD, Director Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03972761     History of Changes
Other Study ID Numbers: 2019-07
2019-A00829-48 ( Other Identifier: ID RCB )
RCAPHM19_0023 ( Other Identifier: Secondary AP-HM number )
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications