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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Marseille、フランス、13354
- Assistance Publique Hôpitaux de Marseille
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Group exposed to cognitive remediation
Computerized cognitive remediation program.
Program performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)
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Functional neuroimaging objectifies the activation of specific areas of the brain
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プラセボコンパレーター：Group not exposed to cognitive remediation
Standard remediation performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)
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Functional neuroimaging objectifies the activation of specific areas of the brain
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Activation of cortical areas
時間枠：24 months
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Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory
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24 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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