Self-defining Memories in Patients With a TBI

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

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-04

Study Completion Date

2016-05-31

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.

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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.

Conditions

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Traumatic Brain Injuries Neurobehavioral Manifestations Cognition Disorders Memory Deficits

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cognitive measures and questionnaires

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

Group Type OTHER

Questionnaires and cognitive measures

Intervention Type OTHER

Interventions

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Questionnaires and cognitive measures

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes