Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe

Traumatic Brain Injury Clinical Trial

— ANOSOGNOSIA  

Official title:

Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02333006
• Other study ID #: 2014-A00110-47
• Status: Recruiting
• Phase: N/A
• First received: December 24, 2014
• Last updated: January 31, 2018
• Start date: February 2015
• Est. completion date: June 2020

Study information

• Verified date: January 2018
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: PHILIPPE AZOUVI, MDPHP
• Phone: 00331 47 10 70 74
• Email: philippe.azouvi[@]rpc.aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Other:
• Questionnaires
Traumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anosognosia score	Questionaire about anosognosia	1h30
Secondary	Neuropsychological score	Neuropsychological tests	1h