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

NCT ID: NCT04562844

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-24

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head Injury Trauma Cognition Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single group for 1 study and multiples singles cases study for rehabilitation
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Social cognition

Group Type EXPERIMENTAL

sociale cognition

Intervention Type OTHER

several social cognition test

Interventions

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sociale cognition

several social cognition test

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SAMSAH-UEROS Arceau Anjou

Angers, , France

Site Status RECRUITING

Raymond Poincaré Hospital

Garches, , France

Site Status NOT_YET_RECRUITING

Ueros Ugecam

Garches, , France

Site Status NOT_YET_RECRUITING

FAM la vie devant soi

Lomme, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Claire Vallat Azouvi, PhD

Role: CONTACT

Phone: 01 47 10 76 46

Email: [email protected]

Isabelle Bossard, Msc

Role: CONTACT

Phone: 0147104615

Email: [email protected]

Facility Contacts

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Saout Virginie, MD PhD

Role: primary

Le Bornec Gaelle, PhD

Role: primary

Vallat Azouvi Claire, PhD

Role: primary

DAVELUY Walter, MD PhD

Role: primary

Other Identifiers

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2018-A00170-55

Identifier Type: -

Identifier Source: org_study_id