Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe (ANOSOGNOSIA)
This study is conducted over 18 months. The main objective of this study is to test and compare the relevance and reliability of different tools for measuring the anosognosia.
Secondary objectives are :
- identify the relevant test who are able to evaluate more specially the cognitive processes involved in anosognosia
- explore the links between the anosognosia manifestations and the psychological manifestations
調査の概要
詳細な説明
This experimental protocol is proposed to 40 patients who have a moderate or severe traumatic brain injury. All of this protocol is 2 hours, tasks are administered in the order named.
To measure anosognosia, this protocol is to administer 4 questionnaires used in clinical routine who have proposed to patients and their therapist and relative who know them well. The chosen measure is the difference between the results of the patient and that of the therapist or relative. Others evaluations are administrated to question the beliefs capacity during 2 certainty of judgment tasks replicated or adapted articles from the literature (tasks of guessing and task of judgments facts).
The patients are also evaluated through several executive tasks (who come from battery of tests called 'Groupe de Reflexion sur l'évaluation des fonctions exécutives') and global cognitive efficiency tasks from the Wechsler Adult Intelligence Scale (involving non-verbal reasoning, psychomotor speed and general knowledge). These different tests measure the capacity of inhibition, mental flexibility, planning and information generation.
At last, mood and coping strategy questionnaires are proposed to patients for complete this protocol.
This protocol are also administered to 40 volunteers who have not had traumatic brain injury to monitor standards in general population (because all these tasks are not systematically standardized).
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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-
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Garches、フランス、92380
- 募集
- Hôpital Raymond Poincaré
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コンタクト：
- PHILIPPE AZOUVI, MDPHD
- 電話番号：0033147107074
- メール：philippe.azouvi@rpc.aphp.fr
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コンタクト：
- SANDRA POTTIER, CRA
- 電話番号：0033147104469
- メール：sandra.pottier@rpc.aphp.fr
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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:
- patients with a moderate or severe traumatic brain injury occurred at least 3 months ago (Glasgow ≤ 12 or duration of post-traumatic amnesia > 1 week)
- patients ≥ 18 years old and who have signed a letter of information
Exclusion Criteria :
- motor, sensitive and phasic disorders who are not allowing the test passation
- neurological or psychiatric antecedents
- patients who refused to participate in the study
- non affiliation to a social security scheme
- patients under guardianship or trusteeship
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：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
他の：Traumatic brain injury questionnaires
Traumatic brain injury patients with anosognosia will answer to quetionnaires about Anosognosia compare to the answer of participant without neurological deficits
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Traumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia
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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 |
|---|---|---|
|
Anosognosia score
時間枠：1h30
|
Questionaire about anosognosia
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1h30
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neuropsychological score
時間枠：1h
|
Neuropsychological tests
|
1h
|
協力者と研究者
捜査官
- スタディチェア：EMILIE DROMER, Psychologue、Raymond Poincaré Hospital
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。