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Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe

Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02333006
Acronym
ANOSOGNOSIA
Enrollment
80
Registered
2015-01-07
Start date
2015-02-28
Completion date
2020-06-30
Last updated
2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Anosognosia

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).

Interventions

OTHERQuestionnaires

Traumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia

Sponsors

Centre d'Investigation Clinique et Technologique 805
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Anosognosia score1h30Questionaire about anosognosia

Secondary

MeasureTime frameDescription
Neuropsychological score1hNeuropsychological tests

Countries

France

Contacts

Primary ContactPHILIPPE AZOUVI, MDPHP
philippe.azouvi@rpc.aphp.fr00331 47 10 70 74

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026