Self-defining Memories in Patients With a TBI

Study Overview
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Brief Summary
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The study will be conducted over 18 months. The main objective of this study is to explore the relationships between autobiographical memory and specific cognitive measures, as well as emotional and behavioural measures in patients who have suffered a moderate to severe TBI. Secondary objectives are to assess the psychometric properties of a self-defining memories questionnaire and to characterize autobiographical memory in the TBI population.

Detailed Description
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A total of 40 participants (20 non-consecutive adults with a moderate or severe TBI and 20 volunteers with any history of neurological or psychiatric disease) will be recruited into the study. The duration of the protocol is 70 minutes. As regards the assessment, three questionnaires will be administered in order to evaluate self-defining memories, apathetic manifestations and anxio-depressive symptoms. In addition, four cognitive measures will be used to assess verbal episodic memory, working memory, cognitive flexibility and verbal fluency.

Official Title
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Self-defining Memories in Patients With a TBI and Their Relationships With Cognitive, Emotional and Behavioural Dimensions

Conditions
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Traumatic Brain Injuries, Neurobehavioral Manifestations, Cognition Disorders, Memory Deficits

Intervention / Treatment
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* Other: Questionnaires and cognitive measures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a moderate or severe TBI occurred at least 6 months ago (initial Glasgow Coma Scale score ≤ 12 or post-traumatic amnesia duration > 1 week) patients ≥ 18 years old and who have signed a letter of information Exclusion Criteria: history of neurological and/or psychiatric disease persistent motor, sensitive and instrumental disorders that could disturb the efficient evaluation of the participant patients who refused to participate in the study non affiliation to a social security scheme patients under guardianship or trusteeship pregnant woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cognitive measures and questionnaires<br>the material of the study will consist of cognitive measures and questionnaires in order to (1) compare the cognitive performances and behavioral manifestations between patients with TBI and volunteers without neurological disorders and (2) to analyze the links between cognitive and behavioural measures in the TBI population | Other: Questionnaires and cognitive measures<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-defining memory score | self-defining memories will be measured using the self-defining memories questionnaire | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| verbal episodic memory score | verbal episodic memory will be measured using the California Verbal Learning Test | 20 minutes | 
| working memory score | working memory will be measured using verbal span task | 10 minutes | 
| cognitive flexibility score | cognitive flexibility will be measured using the Trail Making Test | 5 minutes | 
| verbal fluency score | verbal fluency will be measured using the verbal fluency task | 5 minutes | 
| apathy score | apathetic manifestations will be measured using the Apathy Evaluation Scale | 5 minutes | 
| anxio-depressive score | anxio-depressive symptoms will be measured using the Hospital Anxiety and Depression Scale | 5 minutes |