Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe

NCT ID: NCT02333006

Last Updated: 2018-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2020-06-30

Brief Summary

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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

Detailed Description

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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).

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Traumatic brain injury questionnaires

Traumatic brain injury patients with anosognosia will answer to quetionnaires about Anosognosia compare to the answer of participant without neurological deficits

Group Type OTHER

Questionnaires

Intervention Type OTHER

Traumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia

Interventions

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Questionnaires

Traumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role lead

Responsible Party

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AZOUVI

MDPHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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EMILIE DROMER, Psychologue

Role: STUDY_CHAIR

Raymond Poincaré Hospital

Locations

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Hopital Raymond Poincare

Garches, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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PHILIPPE AZOUVI, MDPHP

Role: CONTACT

00331 47 10 70 74

Facility Contacts

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PHILIPPE AZOUVI, MDPHD

Role: primary

0033147107074

SANDRA POTTIER, CRA

Role: backup

0033147104469

Other Identifiers

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2014-A00110-47

Identifier Type: -

Identifier Source: org_study_id

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