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

Primary Purpose

Head Injury Trauma, Cognition Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sociale cognition
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head Injury Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • SAMSAH-UEROS Arceau AnjouRecruiting
  • Raymond Poincaré Hospital
  • Ueros Ugecam
  • FAM la vie devant soiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Social cognition

Arm Description

Outcomes

Primary Outcome Measures

social cognition evaluation
emotional and sociocognitive measurement by questionnaire
humor and global cognition
attention measurement and mood evolution by questionnaire
social activity measurement
activity measurement and social cognition evaluation by questionnaire

Secondary Outcome Measures

environnemental measurement
questionnaire
mood measurement
questionnaire
quality of life questionnaire
questionnaire

Full Information

First Posted
September 21, 2020
Last Updated
November 18, 2020
Sponsor
Centre d'Investigation Clinique et Technologique 805
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1. Study Identification

Unique Protocol Identification Number
NCT04562844
Brief Title
Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury
Acronym
CogniSo-TC
Official Title
Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
September 24, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury Trauma, Cognition Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group for 1 study and multiples singles cases study for rehabilitation
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social cognition
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
sociale cognition
Intervention Description
several social cognition test
Primary Outcome Measure Information:
Title
social cognition evaluation
Description
emotional and sociocognitive measurement by questionnaire
Time Frame
4 hours
Title
humor and global cognition
Description
attention measurement and mood evolution by questionnaire
Time Frame
4 hours
Title
social activity measurement
Description
activity measurement and social cognition evaluation by questionnaire
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
environnemental measurement
Description
questionnaire
Time Frame
20 min
Title
mood measurement
Description
questionnaire
Time Frame
30 min
Title
quality of life questionnaire
Description
questionnaire
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Vallat Azouvi, PhD
Phone
01 47 10 76 46
Email
claire.vallat-azouvi@univ-paris8.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Bossard, Msc
Phone
0147104615
Email
isabelle.bossard@aphp.fr
Facility Information:
Facility Name
SAMSAH-UEROS Arceau Anjou
City
Angers
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saout Virginie, MD PhD
Facility Name
Raymond Poincaré Hospital
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Le Bornec Gaelle, PhD
Facility Name
Ueros Ugecam
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vallat Azouvi Claire, PhD
Facility Name
FAM la vie devant soi
City
Lomme
ZIP/Postal Code
59160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DAVELUY Walter, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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