Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe (ANOSOGNOSIA)
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
About this trial
This is an interventional other trial for Traumatic Brain Injury focused on measuring Anosognosia
Eligibility 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
Sites / Locations
- Hopital Raymond PoincareRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Traumatic brain injury questionnaires
Arm Description
Traumatic brain injury patients with anosognosia will answer to quetionnaires about Anosognosia compare to the answer of participant without neurological deficits
Outcomes
Primary Outcome Measures
Anosognosia score
Questionaire about anosognosia
Secondary Outcome Measures
Neuropsychological score
Neuropsychological tests
Full Information
NCT ID
NCT02333006
First Posted
December 24, 2014
Last Updated
January 31, 2018
Sponsor
Centre d'Investigation Clinique et Technologique 805
1. Study Identification
Unique Protocol Identification Number
NCT02333006
Brief Title
Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe
Acronym
ANOSOGNOSIA
Official Title
Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Anosognosia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traumatic brain injury questionnaires
Arm Type
Other
Arm Description
Traumatic brain injury patients with anosognosia will answer to quetionnaires about Anosognosia compare to the answer of participant without neurological deficits
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Traumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia
Primary Outcome Measure Information:
Title
Anosognosia score
Description
Questionaire about anosognosia
Time Frame
1h30
Secondary Outcome Measure Information:
Title
Neuropsychological score
Description
Neuropsychological tests
Time Frame
1h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PHILIPPE AZOUVI, MDPHP
Phone
00331 47 10 70 74
Email
philippe.azouvi@rpc.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIE DROMER, Psychologue
Organizational Affiliation
Raymond Poincaré Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PHILIPPE AZOUVI, MDPHD
Phone
0033147107074
Email
philippe.azouvi@rpc.aphp.fr
First Name & Middle Initial & Last Name & Degree
SANDRA POTTIER, CRA
Phone
0033147104469
Email
sandra.pottier@rpc.aphp.fr
12. IPD Sharing Statement
Learn more about this trial
Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe
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