Head Injury TraumaCogniSo-TCNCT04562844
Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury
A study testing sociale cognition in people with Head Injury Trauma and Cognition Disorder, run by Centre d'Investigation Clinique et Technologique 805 at 4 sites in France.
Trial summary
Patients who have suffered moderate to severe traumatic brain injury (TBI) frequently develop behavioural changes, which can have deleterious consequences on interpersonal relationships, social, family and professional reintegration. They are a source of difficulties (burden) for family and friends. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head Injury Trauma, Cognition Disorder
- What is being tested?
- sociale cognition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesFrance
- Study dates
- 24 Sep 2020to 31 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female of legal age,
- Having suffered a moderate to severe traumatic brain injury (Glasgow Coma Scale score of 3 to 12) at least 6 months after the trauma,
- Returned home at least 3 months ago,
- Having given their informed consent,
- Affiliated to the social security system
Who cannot join
- Psychiatric history,
- Persistent post-traumatic amnesia,
- Instrumental disorders that interfere with taking tests (aphasia, agnosia, neurovisual disorders),
- Mood disorders not stabilized under treatment,
- Patient refuses to participate in the study,
- Participation in another cognitive rehabiltation protocol,
- Pregnant or breastfeeding woman.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
SAMSAH-UEROS Arceau Anjou
Angers, 49100
Saout Virginie, MD PhD
- Not yet recruiting
Raymond Poincaré Hospital
Garches, 92380
Le Bornec Gaelle, PhD
- Not yet recruiting
Ueros Ugecam
Garches, 92380
Vallat Azouvi Claire, PhD
- Recruiting
FAM la vie devant soi
Lomme, 59160
DAVELUY Walter, MD PhD
About this study
Patients who have suffered moderate to severe traumatic brain injury (TBI) frequently develop behavioural changes, which can have deleterious consequences on interpersonal relationships, social, family and professional reintegration. They are a source of difficulties (burden) for family and friends. Social cognition covers four functions: recognition of social cues; empathy; attribution of intentions to a third party, or theory of mind; and adjustment of social behaviour according to context. This study has two parts: 1/ Evaluation, using a cognitive approach, of the different components of social cognition after moderate to severe traumatic brain injury, and of its repercussions in daily life and on family and friends.
2/ Creation of a specific re-education method for the different modules of social cognition and study of its effectiveness.
Read the detailed description
First objective: to study in a systematic way in the same group of TBI patients the different domains of social cognition and the relationships between these different sub-domains in these patients, as well as the relationships between these deficits and the more global cognitive functioning (executive functions), and to evaluate their repercussions in daily life (activity limitations and participation restrictions).
Second objective: to develop and evaluate the effectiveness of a specific rehabilitation protocol for social cognition, adjusted to each profile, according to the disorders of the components of social cognition found in each patient. We make the hypothesis that not all patients will present homogeneous deficits and we also wish to bring elements of knowledge on the sub-domains of social cognition that can be "mobilized" by therapeutic means based on cognitive training adapted to each patient. The methodology envisaged is based on an experimental methodology in single repeated case studies, allowing a fine analysis of the architecture of the altered cognitive processes in a given patient and to adapt the rehabilitation protocol in an individualized way.
- Conditions
- Head Injury Trauma, Cognition Disorder
- Being tested
- sociale cognition
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sociale cognitionOther
several social cognition test
| Study group | Role | What they receive |
|---|---|---|
| Social cognition | Experimental | Not described Receives: Other: sociale cognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
social cognition evaluation
emotional and sociocognitive measurement by questionnaire
Measured: 4 hours
humor and global cognition
attention measurement and mood evolution by questionnaire
Measured: 4 hours
social activity measurement
activity measurement and social cognition evaluation by questionnaire
Measured: 1 hour
Secondary outcomes (3)
environnemental measurement
questionnaire
Measured: 20 min
mood measurement
questionnaire
Measured: 30 min
quality of life questionnaire
questionnaire
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start24 Sep 2020
- Primary completion24 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Injury TraumaStudies 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
- Model description
- single group for 1 study and multiples singles cases study for rehabilitation
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562844
- Sponsor's protocol ID
- 2018-A00170-55
- Acronym
- CogniSo-TC
- Status last verified
- Jul 2020
- First submitted
- 21 Sep 2020
- Last updated
- 19 Nov 2020
- 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 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04562844
- Acronym / sponsor ID
- CogniSo-TC / 2018-A00170-55
- Conditions
- Head Injury Trauma, Cognition Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 24 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Sep 2020 (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.
Patients who have suffered moderate to severe traumatic brain injury (TBI) frequently develop behavioural changes, which can have deleterious consequences on interpersonal relationships, social, family and professional reintegration. They are a source of difficulties (burden) for family and friends. Social cognition covers four functions: recognition of social cues; empathy; attribution of intentions to a third party, or theory of mind; and adjustment of social behaviour according to context. This study has two parts: 1/ Evaluation, using a cognitive approach, of the different components of social cognition after moderate to severe traumatic brain injury, and of its repercussions in daily life and on family and friends.
2/ Creation of a specific re-education method for the different modules of social cognition and study of its effectiveness.
Detailed description
First objective: to study in a systematic way in the same group of TBI patients the different domains of social cognition and the relationships between these different sub-domains in these patients, as well as the relationships between these deficits and the more global cognitive functioning (executive functions), and to evaluate their repercussions in daily life (activity limitations and participation restrictions).
Second objective: to develop and evaluate the effectiveness of a specific rehabilitation protocol for social cognition, adjusted to each profile, according to the disorders of the components of social cognition found in each patient. We make the hypothesis that not all patients will present homogeneous deficits and we also wish to bring elements of knowledge on the sub-domains of social cognition that can be "mobilized" by therapeutic means based on cognitive training adapted to each patient. The methodology envisaged is based on an experimental methodology in single repeated case studies, allowing a fine analysis of the architecture of the altered cognitive processes in a given patient and to adapt the rehabilitation protocol in an individualized way.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group for 1 study and multiples singles cases study for rehabilitation
| Arm | Type | Receives |
|---|---|---|
| Social cognition | Experimental | Other: sociale cognition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female of legal age,
- Having suffered a moderate to severe traumatic brain injury (Glasgow Coma Scale score of 3 to 12) at least 6 months after the trauma,
- Returned home at least 3 months ago,
- Having given their informed consent,
- Affiliated to the social security system
Key exclusion criteria (7 listed)
- Psychiatric history,
- Persistent post-traumatic amnesia,
- Instrumental disorders that interfere with taking tests (aphasia, agnosia, neurovisual disorders),
- Mood disorders not stabilized under treatment,
- Patient refuses to participate in the study,
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 |
|---|---|---|
| sociale cognitionseveral social cognition test | Other | Social cognition |
Primary outcome
social cognition evaluation
Time frame: 4 hours
emotional and sociocognitive measurement by questionnaire
humor and global cognition
Time frame: 4 hours
attention measurement and mood evolution by questionnaire
social activity measurement
Time frame: 1 hour
activity measurement and social cognition evaluation by questionnaire
3 secondary outcomes
environnemental measurement
Time frame: 20 min
mood measurement
Time frame: 30 min
quality of life questionnaire
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sociale cognition in people with Head Injury Trauma and Cognition Disorder, run by Centre d'Investigation Clinique et Technologique 805 at 4 sites in France.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Vallat Azouvi, PhD (01 47 10 76 46, claire.vallat-azouvi@univ-paris8.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
social cognition evaluation (time frame: 4 hours). The study lists 3 primary outcomes in all. 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 19 Nov 2020.