Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
Primary Purpose
Cerebral Lesion
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebral Lesion focused on measuring Acquired cerebral lesion, Anger, Agression
Eligibility Criteria
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.
Sites / Locations
- Brugmann University HospitalRecruiting
- Hôpital Universitaire Pitié-Salpêtrière
- Hôpitaux Saint Maurice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with acquired brain injury
Arm Description
Outcomes
Primary Outcome Measures
Questionnaire evaluation by Rasch methodology
questionnaire validity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04034875
Brief Title
Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
Official Title
SOCIALBI, a Rasch Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eric Durand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Lesion
Keywords
Acquired cerebral lesion, Anger, Agression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with acquired brain injury
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
questionnaire
Primary Outcome Measure Information:
Title
Questionnaire evaluation by Rasch methodology
Description
questionnaire validity
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Durand, MD
Phone
3224758121
Email
Eric.DURAND@chu-brugmann.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Durand, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brugmann University Hospital
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Durand, MD
Email
Eric.DURAND@chu-brugmann.be
First Name & Middle Initial & Last Name & Degree
Eric Durand, MD
Facility Name
Hôpital Universitaire Pitié-Salpêtrière
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pradat-Diehl, Pr
Facility Name
Hôpitaux Saint Maurice
City
Saint-Maurice
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chevignard, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
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