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Completed

NCT Number: NCT02680210

Self-defining Memories in Patients With a TBI

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.

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Key information

Conditions

Traumatic Brain Injuries Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognition Disorders Craniocerebral Trauma Memory Deficits Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Raymond Poincaré

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires and cognitive measures

Other

Primary outcomes

  1. self-defining memory score

    Time frame: 20 minutes

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

Secondary outcomes

  1. verbal episodic memory score

    Time frame: 20 minutes

    verbal episodic memory will be measured using the California Verbal Learning Test

  2. working memory score

    Time frame: 10 minutes

    working memory will be measured using verbal span task

  3. cognitive flexibility score

    Time frame: 5 minutes

    cognitive flexibility will be measured using the Trail Making Test

  4. verbal fluency score

    Time frame: 5 minutes

    verbal fluency will be measured using the verbal fluency task

  5. apathy score

    Time frame: 5 minutes

    apathetic manifestations will be measured using the Apathy Evaluation Scale

  6. anxio-depressive score

    Time frame: 5 minutes

    anxio-depressive symptoms will be measured using the Hospital Anxiety and Depression Scale

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Official study title

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

Acronym: IDENTITY

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2016
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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