Traumatic Brain InjuryANOSOGNOSIANCT02333006
Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe
A study testing Questionnaires in people with Traumatic Brain Injury, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
This study is conducted over 18 months. The main objective of this study is to test and compare the relevance and reliability of different tools for measuring the anosognosia. Secondary objectives are : identify the relevant test who are able to evaluate more specially the cognitive processes involved in anosognosia… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Jun 2020
- 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
- patients with a moderate or severe traumatic brain injury occurred at least 3 months ago (Glasgow ≤ 12 or duration of post-traumatic amnesia > 1 week)
- patients ≥ 18 years old and who have signed a letter of information
Who cannot join
- motor, sensitive and phasic disorders who are not allowing the test passation
- neurological or psychiatric antecedents
- patients who refused to participate in the study
- non affiliation to a social security scheme
- patients under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Raymond Poincare
Garches, 92380
PHILIPPE AZOUVI, MDPHD, 0033147107074, philippe.azouvi@rpc.aphp.fr
SANDRA POTTIER, CRA, 0033147104469, sandra.pottier@rpc.aphp.fr
About this study
This study is conducted over 18 months. The main objective of this study is to test and compare the relevance and reliability of different tools for measuring the anosognosia.
Secondary objectives are :
- identify the relevant test who are able to evaluate more specially the cognitive processes involved in anosognosia
- explore the links between the anosognosia manifestations and the psychological manifestations
Read the detailed description
This experimental protocol is proposed to 40 patients who have a moderate or severe traumatic brain injury. All of this protocol is 2 hours, tasks are administered in the order named.
To measure anosognosia, this protocol is to administer 4 questionnaires used in clinical routine who have proposed to patients and their therapist and relative who know them well. The chosen measure is the difference between the results of the patient and that of the therapist or relative. Others evaluations are administrated to question the beliefs capacity during 2 certainty of judgment tasks replicated or adapted articles from the literature (tasks of guessing and task of judgments facts).
The patients are also evaluated through several executive tasks (who come from battery of tests called 'Groupe de Reflexion sur l'évaluation des fonctions exécutives') and global cognitive efficiency tasks from the Wechsler Adult Intelligence Scale (involving non-verbal reasoning, psychomotor speed and general knowledge). These different tests measure the capacity of inhibition, mental flexibility, planning and information generation.
At last, mood and coping strategy questionnaires are proposed to patients for complete this protocol.
This protocol are also administered to 40 volunteers who have not had traumatic brain injury to monitor standards in general population (because all these tasks are not systematically standardized).
- Conditions
- Traumatic Brain Injury
- Being tested
- Questionnaires
- Keywords
- Anosognosia
- Medical subject headings
- Brain Injuries, Traumatic, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Traumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia
| Study group | Role | What they receive |
|---|---|---|
| Traumatic brain injury questionnaires | Other | Traumatic brain injury patients with anosognosia will answer to quetionnaires about Anosognosia compare to the answer of participant without neurological deficits Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anosognosia score
Questionaire about anosognosia
Measured: 1h30
Secondary outcomes (1)
Neuropsychological score
Neuropsychological tests
Measured: 1h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Principal investigator, AZOUVI, Centre d'Investigation Clinique et Technologique 805
- Investigators
- EMILIE DROMER, Psychologue, Study chair, Raymond Poincaré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333006
- Sponsor's protocol ID
- 2014-A00110-47
- Acronym
- ANOSOGNOSIA
- Status last verified
- Jan 2018
- First submitted
- 24 Dec 2014
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe
- ClinicalTrials.gov ID
- NCT02333006
- Acronym / sponsor ID
- ANOSOGNOSIA / 2014-A00110-47
- Conditions
- Traumatic Brain Injury
- Keywords
- Anosognosia
- 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
- Feb 2015
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 7 Jan 2015 (estimated)
- 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.
This study is conducted over 18 months. The main objective of this study is to test and compare the relevance and reliability of different tools for measuring the anosognosia.
Secondary objectives are :
- identify the relevant test who are able to evaluate more specially the cognitive processes involved in anosognosia
- explore the links between the anosognosia manifestations and the psychological manifestations
Detailed description
This experimental protocol is proposed to 40 patients who have a moderate or severe traumatic brain injury. All of this protocol is 2 hours, tasks are administered in the order named.
To measure anosognosia, this protocol is to administer 4 questionnaires used in clinical routine who have proposed to patients and their therapist and relative who know them well. The chosen measure is the difference between the results of the patient and that of the therapist or relative. Others evaluations are administrated to question the beliefs capacity during 2 certainty of judgment tasks replicated or adapted articles from the literature (tasks of guessing and task of judgments facts).
The patients are also evaluated through several executive tasks (who come from battery of tests called 'Groupe de Reflexion sur l'évaluation des fonctions exécutives') and global cognitive efficiency tasks from the Wechsler Adult Intelligence Scale (involving non-verbal reasoning, psychomotor speed and general knowledge). These different tests measure the capacity of inhibition, mental flexibility, planning and information generation.
At last, mood and coping strategy questionnaires are proposed to patients for complete this protocol.
This protocol are also administered to 40 volunteers who have not had traumatic brain injury to monitor standards in general population (because all these tasks are not systematically standardized).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury questionnaires | Other | Other: QuestionnairesTraumatic brain injury patients with anosognosia will answer to quetionnaires about Anosognosia compare to the answer of participant without neurological deficits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with a moderate or severe traumatic brain injury occurred at least 3 months ago (Glasgow ≤ 12 or duration of post-traumatic amnesia > 1 week)
- patients ≥ 18 years old and who have signed a letter of information
Key exclusion criteria (5 listed)
- motor, sensitive and phasic disorders who are not allowing the test passation
- neurological or psychiatric antecedents
- patients who refused to participate in the study
- non affiliation to a social security scheme
- patients under guardianship or trusteeship
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 |
|---|---|---|
| QuestionnairesTraumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia | Other | Traumatic brain injury questionnaires |
Primary outcome
Anosognosia score
Time frame: 1h30
Questionaire about anosognosia
1 secondary outcome
Neuropsychological score
Time frame: 1h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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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.
EMILIE DROMER, Psychologue study chair
Raymond Poincaré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Traumatic Brain Injury, run by Centre d'Investigation Clinique et Technologique 805 at 1 site 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 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: status not confirmed, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 PHILIPPE AZOUVI, MDPHP (00331 47 10 70 74, philippe.azouvi@rpc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anosognosia score (time frame: 1h30). 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 1 Feb 2018.