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

C

Centre d'Investigation Clinique et Technologique 805

Status

Completed

Conditions

Cognition Disorders
Traumatic Brain Injuries
Memory Deficits
Neurobehavioral Manifestations

Treatments

Other: Questionnaires and cognitive measures

Study type

Interventional

Funder types

Other

Identifiers

NCT02680210
2015-A00996-43

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

cognitive measures and questionnaires
Other group
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
Treatment:
Other: Questionnaires and cognitive measures

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems