Self-defining Memories in Patients With a TBI (IDENTITY)
Primary Purpose
Traumatic Brain Injuries, Neurobehavioral Manifestations, Cognition Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires and cognitive measures
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injuries
Eligibility Criteria
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
Sites / Locations
- Hôpital Raymond Poincaré
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
cognitive measures and questionnaires
Arm Description
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
Outcomes
Primary Outcome Measures
self-defining memory score
self-defining memories will be measured using the self-defining memories questionnaire
Secondary Outcome Measures
verbal episodic memory score
verbal episodic memory will be measured using the California Verbal Learning Test
working memory score
working memory will be measured using verbal span task
cognitive flexibility score
cognitive flexibility will be measured using the Trail Making Test
verbal fluency score
verbal fluency will be measured using the verbal fluency task
apathy score
apathetic manifestations will be measured using the Apathy Evaluation Scale
anxio-depressive score
anxio-depressive symptoms will be measured using the Hospital Anxiety and Depression Scale
Full Information
NCT ID
NCT02680210
First Posted
January 29, 2016
Last Updated
May 9, 2019
Sponsor
Centre d'Investigation Clinique et Technologique 805
1. Study Identification
Unique Protocol Identification Number
NCT02680210
Brief Title
Self-defining Memories in Patients With a TBI
Acronym
IDENTITY
Official Title
Self-defining Memories in Patients With a TBI and Their Relationships With Cognitive, Emotional and Behavioural Dimensions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 4, 2016 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injuries, Neurobehavioral Manifestations, Cognition Disorders, Memory Deficits
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cognitive measures and questionnaires
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Questionnaires and cognitive measures
Primary Outcome Measure Information:
Title
self-defining memory score
Description
self-defining memories will be measured using the self-defining memories questionnaire
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
verbal episodic memory score
Description
verbal episodic memory will be measured using the California Verbal Learning Test
Time Frame
20 minutes
Title
working memory score
Description
working memory will be measured using verbal span task
Time Frame
10 minutes
Title
cognitive flexibility score
Description
cognitive flexibility will be measured using the Trail Making Test
Time Frame
5 minutes
Title
verbal fluency score
Description
verbal fluency will be measured using the verbal fluency task
Time Frame
5 minutes
Title
apathy score
Description
apathetic manifestations will be measured using the Apathy Evaluation Scale
Time Frame
5 minutes
Title
anxio-depressive score
Description
anxio-depressive symptoms will be measured using the Hospital Anxiety and Depression Scale
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annabelle Arnould, psychologue
Organizational Affiliation
Hôpital Raymond Poincaré
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Raymond Poincaré
City
Garches
State/Province
Ile De France
ZIP/Postal Code
92380
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Self-defining Memories in Patients With a TBI
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