Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04034875
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Durand, Brugmann University Hospital

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.


Condition or disease Intervention/treatment Phase
Cerebral Lesion Other: Questionnaire Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SOCIALBI, a Rasch Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Patients with acquired brain injury Other: Questionnaire
questionnaire




Primary Outcome Measures :
  1. Questionnaire evaluation by Rasch methodology [ Time Frame: 30 minutes ]
    questionnaire validity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034875


Contacts
Layout table for location contacts
Contact: Eric Durand, MD 3224758121 Eric.DURAND@chu-brugmann.be

Locations
Layout table for location information
Belgium
Brugmann University Hospital Recruiting
Brussels, Belgium, 1020
Contact: Eric Durand, MD       Eric.DURAND@chu-brugmann.be   
Principal Investigator: Eric Durand, MD         
France
Hôpital Universitaire Pitié-Salpêtrière Not yet recruiting
Paris, France
Contact: Pradat-Diehl, Pr         
Hôpitaux Saint Maurice Not yet recruiting
Saint-Maurice, France
Contact: Chevignard, MD PhD         
Sponsors and Collaborators
Eric Durand
Investigators
Layout table for investigator information
Principal Investigator: Eric Durand, MD CHU Brugmann

Layout table for additonal information
Responsible Party: Eric Durand, Head of clinic (Physical medicine), Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT04034875     History of Changes
Other Study ID Numbers: CHUB-SOCIALBI
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Durand, Brugmann University Hospital:
Acquired cerebral lesion
Anger
Agression
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Aggression
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Behavioral Symptoms