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临床试验/NCT02333006
NCT02333006Unknown不适用

Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe

Centre d'Investigation Clinique et Technologique 8052 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Anosognosia score

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Traumatic brain injury questionnaires

Other

Traumatic brain injury patients with anosognosia will answer to quetionnaires about Anosognosia compare to the answer of participant without neurological deficits

干预措施: Questionnaires (Other)

结局指标

主要结局

Anosognosia score

时间窗: 1h30

Questionaire about anosognosia

次要结局

  • Neuropsychological score(1h)

研究者

发起方
Centre d'Investigation Clinique et Technologique 805
申办方类型
Other
责任方
Principal Investigator
主要研究者

AZOUVI

MDPHD

Centre d'Investigation Clinique et Technologique 805

研究点 (2)

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