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

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ClinicalTrials.gov Identifier: NCT04562844
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Study Description
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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.


Condition or disease Intervention/treatment Phase
Head Injury Trauma Cognition Disorder Other: sociale cognition Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single group for 1 study and multiples singles cases study for rehabilitation
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury
Actual Study Start Date : September 24, 2020
Estimated Primary Completion Date : September 24, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Social cognition Other: sociale cognition
several social cognition test


Outcome Measures
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Primary Outcome Measures :
  1. social cognition evaluation [ Time Frame: 4 hours ]
    emotional and sociocognitive measurement by questionnaire

  2. humor and global cognition [ Time Frame: 4 hours ]
    attention measurement and mood evolution by questionnaire

  3. social activity measurement [ Time Frame: 1 hour ]
    activity measurement and social cognition evaluation by questionnaire


Secondary Outcome Measures :
  1. environnemental measurement [ Time Frame: 20 min ]
    questionnaire

  2. mood measurement [ Time Frame: 30 min ]
    questionnaire

  3. quality of life questionnaire [ Time Frame: 1 hour ]
    questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562844


Contacts
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Contact: Claire Vallat Azouvi, PhD 01 47 10 76 46 claire.vallat-azouvi@univ-paris8.fr
Contact: Isabelle Bossard, Msc 0147104615 isabelle.bossard@aphp.fr

Locations
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France
SAMSAH-UEROS Arceau Anjou Recruiting
Angers, France, 49100
Contact: Saout Virginie, MD PhD         
Raymond Poincaré Hospital Not yet recruiting
Garches, France, 92380
Contact: Le Bornec Gaelle, PhD         
Ueros Ugecam Not yet recruiting
Garches, France, 92380
Contact: Vallat Azouvi Claire, PhD         
FAM la vie devant soi Recruiting
Lomme, France, 59160
Contact: DAVELUY Walter, MD PhD         
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
More Information
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Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT04562844    
Other Study ID Numbers: 2018-A00170-55
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Wounds and Injuries
Cognition Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurocognitive Disorders
Mental Disorders