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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04034875
Other study ID # CHUB-SOCIALBI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2019
Est. completion date July 28, 2023

Study information

Verified date May 2024
Source Brugmann University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The incidence of aggression and violent behavior is usually reported to be high after acquired brain injury, around 54%. Behaviors with verbal agression and, less frequently, physical agressions, are described. These behaviors may be linked to the dysfunction of the frontal lobes responsible for executive functions and complex social interactions, or to the dysfunction of the temporal structures that may also be responsible for increased aggression. It is interesting to note that very few scales or specific questionnaires evaluate the factors and co-variables that could lead to aggressive behavior after an acquired brain injury. Such questionnaires are very rare, and none have been validated in French. The objective of this study is to develop a questionnaire in French that aims to assess anger, hostility and aggression after acquired brain injury. The psychometric qualities of this questionnaire will be evaluated using the Rasch probabilistic model. The development of such a tool will be of major interest for clinical practice and future clinical research.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 28, 2023
Est. primary completion date July 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients of the CHU Brugmann Hospital - Central neurological pathology of vascular or traumatic origin, acute or chronic (known since more than one year). Exclusion Criteria: - Pregnant or lactating women - Presence or antecedents of psychiatric disease - Degenerative pathology (ex: Parkinson...) - Antecedents of other neurologic pathologies before the acquired lesion - Oral or written comprehension dysfunctions.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
questionnaire

Locations

Country Name City State
Belgium Brugmann University Hospital Brussels
France Hôpital Universitaire Pitié-Salpêtrière Paris
France Hôpitaux Saint Maurice Saint-Maurice

Sponsors (1)

Lead Sponsor Collaborator
Brugmann University Hospital

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Questionnaire evaluation by Rasch methodology questionnaire validity 30 minutes
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