Self-defining Memories in Patients With a TBI (IDENTITY)

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

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.

Study Overview

• Status: Completed
• Conditions: Neurobehavioral Manifestations; Cognition Disorders; Memory Deficits; Traumatic Brain Injuries
• Intervention / Treatment: Other: Questionnaires and cognitive measures

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Garches, Ile De France, France, 92380
      • Hopital Raymond Poincare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: Questionnaires and cognitive measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-defining memory score	self-defining memories will be measured using the self-defining memories questionnaire	20 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Investigators: Study Chair: Annabelle Arnould, psychologue, Hopital Raymond Poincare

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimate): February 11, 2016

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Neurobehavioral Manifestations; Cognition Disorders; Memory Disorders
• Other Study ID Numbers: 2015-A00996-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO