Self-defining Memories in Patients With a TBI

Not Applicable

Completed

• Conditions: Cognition Disorders; Memory Deficits; Traumatic Brain Injuries; Neurobehavioral Manifestations
• Interventions: Other: Questionnaires and cognitive measures

• Registration Number: NCT02680210
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-01-29
• Study Start: 2016-02-04
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-11
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cognitive measures and questionnaires	Questionnaires and cognitive measures	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

Primary Outcome Measures

Name	Time	Method
self-defining memory score	20 minutes	self-defining memories will be measured using the self-defining memories questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Raymond Poincaré; 🇫🇷 Garches, Ile De France, France