Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury (CogniSo-TC)

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.

Study Overview

• Status: Recruiting
• Conditions: Cognition Disorder; Head Injury Trauma
• Intervention / Treatment: Other: sociale cognition

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Vallat Azouvi, PhD; Phone Number: 01 47 10 76 46; Email: claire.vallat-azouvi@univ-paris8.fr
• Study Contact Backup: Name: Isabelle Bossard, Msc; Phone Number: 0147104615; Email: isabelle.bossard@aphp.fr

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • SAMSAH-UEROS Arceau Anjou
    • Contact: Saout Virginie, MD PhD
  • Garches, France, 92380
    • Not yet recruiting
    • Raymond Poincaré Hospital
    • Contact: Le Bornec Gaelle, PhD
  • Garches, France, 92380
    • Not yet recruiting
    • Ueros Ugecam
    • Contact: Vallat Azouvi Claire, PhD
  • Lomme, France, 59160
    • Recruiting
    • FAM la vie devant soi
    • Contact: DAVELUY Walter, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social cognition	Other: sociale cognition; several social cognition test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
environnemental measurement	questionnaire	20 min
mood measurement	questionnaire	30 min
quality of life questionnaire	questionnaire	1 hour

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Anticipated): September 24, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Cognition Disorders; Craniocerebral Trauma
• Other Study ID Numbers: 2018-A00170-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No