Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe

NCT02333006 | Unknown

• 1 other identifier: 2014-A00110-47
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Traumatic Brain Injury

Keywords

Anosognosia

Outcome Measures

Primary Outcomes (1)

• Anosognosia score

  Questionaire about anosognosia

  1h30

Secondary Outcomes (1)

• Neuropsychological score

  1h

Study Arms (1)

Traumatic brain injury questionnaires

OTHER

Traumatic brain injury patients with anosognosia will answer to quetionnaires about Anosognosia compare to the answer of participant without neurological deficits

Other: Questionnaires

Interventions

Questionnaires OTHER

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

Traumatic brain injury questionnaires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead

Study Sites (1)

Hopital Raymond Poincare

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Agnosia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• EMILIE DROMER, Psychologue

  Raymond Poincaré Hospital

  STUDY CHAIR

Central Study Contacts

PHILIPPE AZOUVI, MDPHP

CONTACT

00331 47 10 70 74; philippe.azouvi@rpc.aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDPHD

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: January 7, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

FR (1)