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Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe (ANOSOGNOSIA)

C

Centre d'Investigation Clinique et Technologique 805

Status

Unknown

Conditions

Traumatic Brain Injury

Treatments

Other: Questionnaires

Study type

Interventional

Funder types

Other

Identifiers

NCT02333006
2014-A00110-47

Details and patient eligibility

About

This study is conducted over 18 months. The main objective of this study is to test and compare the relevance and reliability of different tools for measuring the anosognosia.

Secondary objectives are :

  • identify the relevant test who are able to evaluate more specially the cognitive processes involved in anosognosia
  • explore the links between the anosognosia manifestations and the psychological manifestations

Full description

This experimental protocol is proposed to 40 patients who have a moderate or severe traumatic brain injury. All of this protocol is 2 hours, tasks are administered in the order named.

To measure anosognosia, this protocol is to administer 4 questionnaires used in clinical routine who have proposed to patients and their therapist and relative who know them well. The chosen measure is the difference between the results of the patient and that of the therapist or relative. Others evaluations are administrated to question the beliefs capacity during 2 certainty of judgment tasks replicated or adapted articles from the literature (tasks of guessing and task of judgments facts).

The patients are also evaluated through several executive tasks (who come from battery of tests called 'Groupe de Reflexion sur l'évaluation des fonctions exécutives') and global cognitive efficiency tasks from the Wechsler Adult Intelligence Scale (involving non-verbal reasoning, psychomotor speed and general knowledge). These different tests measure the capacity of inhibition, mental flexibility, planning and information generation.

At last, mood and coping strategy questionnaires are proposed to patients for complete this protocol.

This protocol are also administered to 40 volunteers who have not had traumatic brain injury to monitor standards in general population (because all these tasks are not systematically standardized).

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • patients with a moderate or severe traumatic brain injury occurred at least 3 months ago (Glasgow ≤ 12 or duration of post-traumatic amnesia > 1 week)
  • patients ≥ 18 years old and who have signed a letter of information

Exclusion Criteria :

  • motor, sensitive and phasic disorders who are not allowing the test passation
  • neurological or psychiatric antecedents
  • patients who refused to participate in the study
  • non affiliation to a social security scheme
  • patients under guardianship or trusteeship

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Traumatic brain injury questionnaires
Other group
Description:
Traumatic brain injury patients with anosognosia will answer to quetionnaires about Anosognosia compare to the answer of participant without neurological deficits
Treatment:
Other: Questionnaires

Trial contacts and locations

1

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Central trial contact

PHILIPPE AZOUVI, MDPHP

Data sourced from clinicaltrials.gov

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