NCT04034875

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2023

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

4.3 years

First QC Date

July 23, 2019

Last Update Submit

May 7, 2024

Conditions

Keywords

Acquired cerebral lesionAngerAggression

Outcome Measures

Primary Outcomes (1)

  • Questionnaire evaluation by Rasch methodology

    questionnaire validity

    30 minutes

Study Arms (1)

Patients with acquired brain injury

EXPERIMENTAL
Other: Questionnaire

Interventions

questionnaire

Patients with acquired brain injury

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of the CHU Brugmann Hospital
  • Central neurological pathology of vascular or traumatic origin, acute or chronic (known since more than one year).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Brugmann University Hospital

Brussels, 1020, Belgium

Location

Hôpital Universitaire Pitié-Salpêtrière

Paris, France

Location

Hôpitaux Saint Maurice

Saint-Maurice, France

Location

MeSH Terms

Conditions

Aggression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Eric Durand, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinical trial unit

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 26, 2019

Study Start

April 9, 2019

Primary Completion

July 28, 2023

Study Completion

July 28, 2023

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations