Cerebral LesionNCT04034875
Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
A study testing Questionnaire in people with Cerebral Lesion, run by Brugmann University Hospital at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Lesion
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Apr 2019to 28 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of the CHU Brugmann Hospital
- Central neurological pathology of vascular or traumatic origin, acute or chronic (known since more than one year).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Hôpital Universitaire Pitié-Salpêtrière
Paris
Hôpitaux Saint Maurice
Saint-Maurice
About this study
Official title: SOCIALBI, a Rasch Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
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.
Read more
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.
- Conditions
- Cerebral Lesion
- Being tested
- Questionnaire
- Keywords
- Acquired cerebral lesion, Anger, Aggression
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patients with acquired brain injury | Experimental | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire evaluation by Rasch methodology
questionnaire validity
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start9 Apr 2019
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Besse-Hammer, Brugmann University Hospital
- Investigators
- Eric Durand, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034875
- Sponsor's protocol ID
- CHUB-SOCIALBI
- Status last verified
- May 2024
- First submitted
- 23 Jul 2019
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOCIALBI, a Rasch Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
- ClinicalTrials.gov ID
- NCT04034875
- Acronym / sponsor ID
- CHUB-SOCIALBI
- Conditions
- Cerebral Lesion
- Keywords
- Acquired cerebral lesion, Anger, Aggression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acquired brain injury | Experimental | Other: Questionnaire |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of the CHU Brugmann Hospital
- Central neurological pathology of vascular or traumatic origin, acute or chronic (known since more than one year).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairequestionnaire | Other | Patients with acquired brain injury |
Primary outcome
Questionnaire evaluation by Rasch methodology
Time frame: 30 minutes
questionnaire validity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
Related trials for Cerebral Lesion
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Active, not recruiting
MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
Brain Tumor
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Durand, MD principal investigator
CHU Brugmann
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Cerebral Lesion, run by Brugmann University Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire evaluation by Rasch methodology (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.