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Self-defining Memories in Patients With a TBI

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02680210
Acronym
IDENTITY
Enrollment
32
Registered
2016-02-11
Start date
2016-02-04
Completion date
2016-05-31
Last updated
2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERQuestionnaires and cognitive measures

Sponsors

Centre d'Investigation Clinique et Technologique 805
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
self-defining memory score20 minutesself-defining memories will be measured using the self-defining memories questionnaire

Secondary

MeasureTime frameDescription
working memory score10 minutesworking memory will be measured using verbal span task
cognitive flexibility score5 minutescognitive flexibility will be measured using the Trail Making Test
verbal episodic memory score20 minutesverbal episodic memory will be measured using the California Verbal Learning Test
apathy score5 minutesapathetic manifestations will be measured using the Apathy Evaluation Scale
anxio-depressive score5 minutesanxio-depressive symptoms will be measured using the Hospital Anxiety and Depression Scale
verbal fluency score5 minutesverbal fluency will be measured using the verbal fluency task

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026