Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- social cognition evaluation
研究概览
简要总结
Patients who have suffered moderate to severe traumatic brain injury (TBI) frequently develop behavioural changes, which can have deleterious consequences on interpersonal relationships, social, family and professional reintegration. They are a source of difficulties (burden) for family and friends. Social cognition covers four functions: recognition of social cues; empathy; attribution of intentions to a third party, or theory of mind; and adjustment of social behaviour according to context. This study has two parts: 1/ Evaluation, using a cognitive approach, of the different components of social cognition after moderate to severe traumatic brain injury, and of its repercussions in daily life and on family and friends.
2/ Creation of a specific re-education method for the different modules of social cognition and study of its effectiveness.
详细描述
First objective: to study in a systematic way in the same group of TBI patients the different domains of social cognition and the relationships between these different sub-domains in these patients, as well as the relationships between these deficits and the more global cognitive functioning (executive functions), and to evaluate their repercussions in daily life (activity limitations and participation restrictions).
Second objective: to develop and evaluate the effectiveness of a specific rehabilitation protocol for social cognition, adjusted to each profile, according to the disorders of the components of social cognition found in each patient. We make the hypothesis that not all patients will present homogeneous deficits and we also wish to bring elements of knowledge on the sub-domains of social cognition that can be "mobilized" by therapeutic means based on cognitive training adapted to each patient. The methodology envisaged is based on an experimental methodology in single repeated case studies, allowing a fine analysis of the architecture of the altered cognitive processes in a given patient and to adapt the rehabilitation protocol in an individualized way.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Male or female of legal age,
- •Having suffered a moderate to severe traumatic brain injury (Glasgow Coma Scale score of 3 to 12) at least 6 months after the trauma,
- •Returned home at least 3 months ago,
- •Having given their informed consent,
- •Affiliated to the social security system
排除标准
- •Psychiatric history,
- •Persistent post-traumatic amnesia,
- •Instrumental disorders that interfere with taking tests (aphasia, agnosia, neurovisual disorders),
- •Mood disorders not stabilized under treatment,
- •Patient refuses to participate in the study,
- •Participation in another cognitive rehabiltation protocol,
- •Pregnant or breastfeeding woman.
结局指标
主要结局
social cognition evaluation
时间窗: 4 hours
emotional and sociocognitive measurement by questionnaire
humor and global cognition
时间窗: 4 hours
attention measurement and mood evolution by questionnaire
social activity measurement
时间窗: 1 hour
activity measurement and social cognition evaluation by questionnaire
次要结局
- quality of life questionnaire(1 hour)
- environnemental measurement(20 min)
- mood measurement(30 min)