An interventional study of Questionnaires and cognitive measures in Traumatic Brain Injuries, Neurobehavioral Manifestations and Cognition Disorders, sponsored by Centre d'Investigation Clinique et Technologique 805. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-13.
Sponsored by Centre d'Investigation Clinique et Technologique 805 · Not applicable, Interventional, and Treatment
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 32 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Centre d'Investigation Clinique et Technologique 805 is the lead sponsor of 74 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
self-defining memory score
self-defining memories will be measured using the self-defining memories questionnaire
Time frame: 20 minutes
verbal episodic memory score
verbal episodic memory will be measured using the California Verbal Learning Test
Time frame: 20 minutes
working memory score
working memory will be measured using verbal span task
Time frame: 10 minutes
cognitive flexibility score
cognitive flexibility will be measured using the Trail Making Test
Time frame: 5 minutes
verbal fluency score
verbal fluency will be measured using the verbal fluency task
Time frame: 5 minutes
apathy score
apathetic manifestations will be measured using the Apathy Evaluation Scale
Time frame: 5 minutes
anxio-depressive score
anxio-depressive symptoms will be measured using the Hospital Anxiety and Depression Scale
Time frame: 5 minutes
Plan to share: No
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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Centre d'Investigation Clinique et Technologique 805