Self-defining Memories in Patients With a TBI and Their Relationships With Cognitive, Emotional and Behavioural Dimensions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- self-defining memory score
研究概览
简要总结
The study will be conducted over 18 months. The main objective of this study is to explore the relationships between autobiographical memory and specific cognitive measures, as well as emotional and behavioural measures in patients who have suffered a moderate to severe TBI. Secondary objectives are to assess the psychometric properties of a self-defining memories questionnaire and to characterize autobiographical memory in the TBI population.
详细描述
A total of 40 participants (20 non-consecutive adults with a moderate or severe TBI and 20 volunteers with any history of neurological or psychiatric disease) will be recruited into the study. The duration of the protocol is 70 minutes. As regards the assessment, three questionnaires will be administered in order to evaluate self-defining memories, apathetic manifestations and anxio-depressive symptoms. In addition, four cognitive measures will be used to assess verbal episodic memory, working memory, cognitive flexibility and verbal fluency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 TBI occurred at least 6 months ago (initial Glasgow Coma Scale score ≤ 12 or post-traumatic amnesia duration > 1 week)
- •patients ≥ 18 years old and who have signed a letter of information
排除标准
- •history of neurological and/or psychiatric disease
- •persistent motor, sensitive and instrumental disorders that could disturb the efficient evaluation of the participant
- •patients who refused to participate in the study
- •non affiliation to a social security scheme
- •patients under guardianship or trusteeship
- •pregnant woman
研究组 & 干预措施
cognitive measures and questionnaires
the material of the study will consist of cognitive measures and questionnaires in order to (1) compare the cognitive performances and behavioral manifestations between patients with TBI and volunteers without neurological disorders and (2) to analyze the links between cognitive and behavioural measures in the TBI population
干预措施: Questionnaires and cognitive measures (Other)
结局指标
主要结局
self-defining memory score
时间窗: 20 minutes
self-defining memories will be measured using the self-defining memories questionnaire
次要结局
- cognitive flexibility score(5 minutes)
- verbal fluency score(5 minutes)
- apathy score(5 minutes)
- anxio-depressive score(5 minutes)
- verbal episodic memory score(20 minutes)
- working memory score(10 minutes)
研究者
AZOUVI
Principal investigator
Centre d'Investigation Clinique et Technologique 805