Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe (ANOSOGNOSIA)
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|ClinicalTrials.gov Identifier: NCT02333006|
Recruitment Status : Recruiting
First Posted : January 7, 2015
Last Update Posted : February 1, 2018
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|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Traumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia
- Anosognosia score [ Time Frame: 1h30 ]Questionaire about anosognosia
- Neuropsychological score [ Time Frame: 1h ]Neuropsychological tests
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 ClinicalTrials.gov identifier (NCT number): NCT02333006
|Contact: PHILIPPE AZOUVI, MDPHP||00331 47 10 70 email@example.com|
|Hopital Raymond Poincare||Recruiting|
|Garches, France, 92380|
|Contact: PHILIPPE AZOUVI, MDPHD 0033147107074 firstname.lastname@example.org|
|Contact: SANDRA POTTIER, CRA 0033147104469 email@example.com|
|Study Chair:||EMILIE DROMER, Psychologue||Raymond Poincaré Hospital|