- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02333006
Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe (ANOSOGNOSIA)
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
Study Overview
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: PHILIPPE AZOUVI, MDPHP
- Phone Number: 00331 47 10 70 74
- Email: philippe.azouvi@rpc.aphp.fr
Study Locations
-
-
-
Garches, France, 92380
- Recruiting
- Hôpital Raymond Poincaré
-
Contact:
- PHILIPPE AZOUVI, MDPHD
- Phone Number: 0033147107074
- Email: philippe.azouvi@rpc.aphp.fr
-
Contact:
- SANDRA POTTIER, CRA
- Phone Number: 0033147104469
- Email: sandra.pottier@rpc.aphp.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anosognosia score
Time Frame: 1h30
|
Questionaire about anosognosia
|
1h30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychological score
Time Frame: 1h
|
Neuropsychological tests
|
1h
|
Collaborators and Investigators
Investigators
- Study Chair: EMILIE DROMER, Psychologue, Raymond Poincaré Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A00110-47
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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