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Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe (ANOSOGNOSIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02333006
Recruitment Status : Recruiting
First Posted : January 7, 2015
Last Update Posted : February 1, 2018
Information provided by (Responsible Party):
AZOUVI, Centre d'Investigation Clinique et Technologique 805

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Other: Questionnaires Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe
Study Start Date : February 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Other: Questionnaires
Traumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia

Primary Outcome Measures :
  1. Anosognosia score [ Time Frame: 1h30 ]
    Questionaire about anosognosia

Secondary Outcome Measures :
  1. Neuropsychological score [ Time Frame: 1h ]
    Neuropsychological tests

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02333006

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Contact: PHILIPPE AZOUVI, MDPHP 00331 47 10 70 74

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Hopital Raymond Poincare Recruiting
Garches, France, 92380
Contact: PHILIPPE AZOUVI, MDPHD    0033147107074   
Contact: SANDRA POTTIER, CRA    0033147104469   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
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Study Chair: EMILIE DROMER, Psychologue Raymond Poincaré Hospital

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Responsible Party: AZOUVI, MDPHD, Centre d'Investigation Clinique et Technologique 805 Identifier: NCT02333006     History of Changes
Other Study ID Numbers: 2014-A00110-47
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Keywords provided by AZOUVI, Centre d'Investigation Clinique et Technologique 805:
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms