Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury

Cognition Disorder Clinical Trial

— CogniSo-TC  

Official title:

Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04562844
• Other study ID #: 2018-A00170-55
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2020
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: Claire Vallat Azouvi, PhD
• Phone: 01 47 10 76 46
• Email: claire.vallat-azouvi[@]univ-paris8.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cognition Disorder
• Cognition Disorders
• Craniocerebral Trauma
• Head Injury Trauma
• Wounds and Injuries

Intervention

Other:
• sociale cognition
several social cognition test

Locations

Country	Name	City	State
France	SAMSAH-UEROS Arceau Anjou	Angers
France	Raymond Poincaré Hospital	Garches
France	Ueros Ugecam	Garches
France	FAM la vie devant soi	Lomme

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	social cognition evaluation	emotional and sociocognitive measurement by questionnaire	4 hours
Primary	humor and global cognition	attention measurement and mood evolution by questionnaire	4 hours
Primary	social activity measurement	activity measurement and social cognition evaluation by questionnaire	1 hour
Secondary	environnemental measurement	questionnaire	20 min
Secondary	mood measurement	questionnaire	30 min
Secondary	quality of life questionnaire	questionnaire	1 hour