Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury
- Conditions
- Head Injury TraumaCognition Disorder
- Interventions
- Other: sociale cognition
- Registration Number
- NCT04562844
- Lead Sponsor
- Centre d'Investigation Clinique et Technologique 805
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Social cognition sociale cognition -
- Primary Outcome Measures
Name Time Method social cognition evaluation 4 hours emotional and sociocognitive measurement by questionnaire
humor and global cognition 4 hours attention measurement and mood evolution by questionnaire
social activity measurement 1 hour activity measurement and social cognition evaluation by questionnaire
- Secondary Outcome Measures
Name Time Method quality of life questionnaire 1 hour questionnaire
environnemental measurement 20 min questionnaire
mood measurement 30 min questionnaire
Trial Locations
- Locations (4)
Ueros Ugecam
🇫🇷Garches, France
FAM la vie devant soi
🇫🇷Lomme, France
SAMSAH-UEROS Arceau Anjou
🇫🇷Angers, France
Raymond Poincaré Hospital
🇫🇷Garches, France