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

Last updated: November 18, 2020
Sponsor: Centre d'Investigation Clinique et Technologique 805
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Injury

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT04562844
2018-A00170-55
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female of legal age,
  • Having suffered a moderate to severe traumatic brain injury (Glasgow Coma Scale scoreof 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

Exclusion Criteria:

  • Psychiatric history,
  • Persistent post-traumatic amnesia,
  • Instrumental disorders that interfere with taking tests (aphasia, agnosia, neurovisualdisorders),
  • Mood disorders not stabilized under treatment,
  • Patient refuses to participate in the study,
  • Participation in another cognitive rehabiltation protocol,
  • Pregnant or breastfeeding woman.

Study Design

Total Participants: 80
Study Start date:
September 24, 2020
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • SAMSAH-UEROS Arceau Anjou

    Angers, 49100
    France

    Active - Recruiting

  • Raymond Poincaré Hospital

    Garches, 92380
    France

    Site Not Available

  • Ueros Ugecam

    Garches, 92380
    France

    Site Not Available

  • FAM la vie devant soi

    Lomme, 59160
    France

    Active - Recruiting

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