Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe
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
- 是
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
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
AZOUVI
MDPHD
Centre d'Investigation Clinique et Technologique 805
