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

• Sponsor: Centre d'Investigation Clinique et Technologique 805 (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04562844
• Collaborator: (none)
• Enrollment: 80
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 39.2
• Patients Per Site: 20
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head Injury Trauma; Cognition Disorder	Other: sociale cognition	N/A

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

• Study Type: Interventional
• Anticipated 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 rehabilitationsingle 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: Sep 24, 2020
• Anticipated Primary Completion Date: Sep 24, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. social cognition evaluation [4 hours]

   emotional and sociocognitive measurement by questionnaire

2. humor and global cognition [4 hours]

   attention measurement and mood evolution by questionnaire

3. social activity measurement [1 hour]

   activity measurement and social cognition evaluation by questionnaire

Secondary Outcome Measures

1. environnemental measurement [20 min]

   questionnaire

2. mood measurement [30 min]

   questionnaire

3. quality of life questionnaire [1 hour]

   questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	SAMSAH-UEROS Arceau Anjou	Angers		France	49100
2	Raymond Poincaré Hospital	Garches		France	92380
3	Ueros Ugecam	Garches		France	92380
4	FAM la vie devant soi	Lomme		France	59160

Sponsors and Collaborators

• Centre d'Investigation Clinique et Technologique 805

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre d'Investigation Clinique et Technologique 805
• ClinicalTrials.gov Identifier: NCT04562844
• Other Study ID Numbers: 2018-A00170-55
• First Posted: Sep 24, 2020
• Last Update Posted: Nov 19, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Wounds and Injuries; Cognition Disorders

Study Results

No Results Posted as of Nov 19, 2020