Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury
CogniSo-TC
1 other identifier
interventional
80
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2020
CompletedFirst Posted
Study publicly available on registry
September 24, 2020
CompletedStudy Start
First participant enrolled
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedNovember 19, 2020
July 1, 2020
3 years
September 21, 2020
November 18, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
social cognition evaluation
emotional and sociocognitive measurement by questionnaire
4 hours
humor and global cognition
attention measurement and mood evolution by questionnaire
4 hours
social activity measurement
activity measurement and social cognition evaluation by questionnaire
1 hour
Secondary Outcomes (3)
environnemental measurement
20 min
mood measurement
30 min
quality of life questionnaire
1 hour
Study Arms (1)
Social cognition
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
SAMSAH-UEROS Arceau Anjou
Angers, 49100, France
Raymond Poincaré Hospital
Garches, 92380, France
Ueros Ugecam
Garches, 92380, France
FAM la vie devant soi
Lomme, 59160, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2020
First Posted
September 24, 2020
Study Start
September 24, 2020
Primary Completion
September 24, 2023
Study Completion
December 31, 2023
Last Updated
November 19, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share