Clinical trial NCT04562844: Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury
Official title: Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head Injury Trauma
Cognition Disorder
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group for 1 study and multiples singles cases study for rehabilitation
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: social cognition evaluation
timeFrame: 4 hours
measure: humor and global cognition
timeFrame: 4 hours
measure: social activity measurement
timeFrame: 1 hour
Secondary outcomes:
measure: environnemental measurement
timeFrame: 20 min
measure: mood measurement
timeFrame: 30 min
measure: quality of life questionnaire
timeFrame: 1 hour
Other outcomes:
Locations:
city: Angers
country: France
facility: SAMSAH-UEROS Arceau Anjou
city: Garches
country: France
facility: Raymond Poincaré Hospital
city: Garches
country: France
facility: Ueros Ugecam
city: Lomme
country: France
facility: FAM la vie devant soi
Study officials:
References: