Self-defining Memories in Patients With a TBI

NCT02680210 | Completed DMC

• 1 other identifier: 2015-A00996-43
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• self-defining memory score

  self-defining memories will be measured using the self-defining memories questionnaire

  20 minutes

Secondary Outcomes (6)

• verbal episodic memory score

  20 minutes

• working memory score

  10 minutes

• cognitive flexibility score

  5 minutes

• verbal fluency score

  5 minutes

• apathy score

  5 minutes

Study Arms (1)

cognitive measures and questionnaires

OTHER

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

Interventions

Questionnaires and cognitive measures OTHER

cognitive measures and questionnaires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead

Study Sites (1)

Hôpital Raymond Poincaré

Garches, Île-de-France Region, 92380, France

Location

MeSH Terms

Conditions

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

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Annabelle Arnould, psychologue

  Hôpital Raymond Poincaré

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 11, 2016
• Study Start: February 4, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)