Self-defining Memories in Patients With a TBI

Cognition Disorders Clinical Trial

— IDENTITY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680210
• Other study ID #: 2015-A00996-43
• Status: Completed
• Phase: N/A
• Start date: February 4, 2016
• Est. completion date: May 2016

Study information

• Verified date: May 2019
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Questionnaires and cognitive measures

Locations

Country	Name	City	State
France	Hôpital Raymond Poincaré	Garches	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-defining memory score	self-defining memories will be measured using the self-defining memories questionnaire	20 minutes
Secondary	verbal episodic memory score	verbal episodic memory will be measured using the California Verbal Learning Test	20 minutes
Secondary	working memory score	working memory will be measured using verbal span task	10 minutes
Secondary	cognitive flexibility score	cognitive flexibility will be measured using the Trail Making Test	5 minutes
Secondary	verbal fluency score	verbal fluency will be measured using the verbal fluency task	5 minutes
Secondary	apathy score	apathetic manifestations will be measured using the Apathy Evaluation Scale	5 minutes
Secondary	anxio-depressive score	anxio-depressive symptoms will be measured using the Hospital Anxiety and Depression Scale	5 minutes