Traumatic Brain InjuriesIDENTITYNCT02680210
Self-defining Memories in Patients With a TBI
A study testing Questionnaires and cognitive measures in people with Traumatic Brain Injuries and Neurobehavioral Manifestations, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
The study will be conducted over 18 months. The main objective of this study is to explore the relationships between autobiographical memory and specific cognitive measures, as well as emotional and behavioural measures in patients who have suffered a moderate to severe TBI. 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 Injuries, Neurobehavioral Manifestations, Cognition Disorders
- What is being tested?
- Questionnaires and cognitive measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2016to May 2016
- 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 TBI occurred at least 6 months ago (initial Glasgow Coma Scale score ≤ 12 or post-traumatic amnesia duration > 1 week)
- patients ≥ 18 years old and who have signed a letter of information
Who cannot join
- history of neurological and/or psychiatric disease
- persistent motor, sensitive and instrumental disorders that could disturb the efficient evaluation of the participant
- patients who refused to participate in the study
- non affiliation to a social security scheme
- patients under guardianship or trusteeship
- pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-defining Memories in Patients With a TBI and Their Relationships With Cognitive, Emotional and Behavioural Dimensions
The study will be conducted over 18 months. The main objective of this study is to explore the relationships between autobiographical memory and specific cognitive measures, as well as emotional and behavioural measures in patients who have suffered a moderate to severe TBI. Secondary objectives are to assess the psychometric properties of a self-defining memories questionnaire and to characterize autobiographical memory in the TBI population.
Read the detailed description
A total of 40 participants (20 non-consecutive adults with a moderate or severe TBI and 20 volunteers with any history of neurological or psychiatric disease) will be recruited into the study. The duration of the protocol is 70 minutes. As regards the assessment, three questionnaires will be administered in order to evaluate self-defining memories, apathetic manifestations and anxio-depressive symptoms. In addition, four cognitive measures will be used to assess verbal episodic memory, working memory, cognitive flexibility and verbal fluency.
- Conditions
- Traumatic Brain Injuries, Neurobehavioral Manifestations, Cognition Disorders, Memory Deficits
- Being tested
- Questionnaires and cognitive measures
- Medical subject headings
- Brain Injuries, Traumatic, Neurobehavioral Manifestations, Cognition Disorders, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and cognitive measuresOther
| Study group | Role | What they receive |
|---|---|---|
| cognitive measures and questionnaires | Other | the material of the study will consist of cognitive measures and questionnaires in order to (1) compare the cognitive performances and behavioral manifestations between patients with TBI and volunteers without neurological disorders and (2) to analyze the links between cognitive and behavioural measures in the TBI population Receives: Other: Questionnaires and cognitive measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-defining memory score
self-defining memories will be measured using the self-defining memories questionnaire
Measured: 20 minutes
Secondary outcomes (6)
verbal episodic memory score
verbal episodic memory will be measured using the California Verbal Learning Test
Measured: 20 minutes
working memory score
working memory will be measured using verbal span task
Measured: 10 minutes
cognitive flexibility score
cognitive flexibility will be measured using the Trail Making Test
Measured: 5 minutes
verbal fluency score
verbal fluency will be measured using the verbal fluency task
Measured: 5 minutes
apathy score
apathetic manifestations will be measured using the Apathy Evaluation Scale
Measured: 5 minutes
anxio-depressive score
anxio-depressive symptoms will be measured using the Hospital Anxiety and Depression Scale
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study start4 Feb 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuriesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
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
- Annabelle Arnould, psychologue, Study chair, Hôpital Raymond Poincaré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680210
- Sponsor's protocol ID
- 2015-A00996-43
- Acronym
- IDENTITY
- Status last verified
- May 2019
- First submitted
- 29 Jan 2016
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-defining Memories in Patients With a TBI and Their Relationships With Cognitive, Emotional and Behavioural Dimensions
- ClinicalTrials.gov ID
- NCT02680210
- Acronym / sponsor ID
- IDENTITY / 2015-A00996-43
- Conditions
- Traumatic Brain Injuries, Neurobehavioral Manifestations, Cognition Disorders, Memory Deficits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Feb 2016 (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.
The study will be conducted over 18 months. The main objective of this study is to explore the relationships between autobiographical memory and specific cognitive measures, as well as emotional and behavioural measures in patients who have suffered a moderate to severe TBI. Secondary objectives are to assess the psychometric properties of a self-defining memories questionnaire and to characterize autobiographical memory in the TBI population.
Detailed description
A total of 40 participants (20 non-consecutive adults with a moderate or severe TBI and 20 volunteers with any history of neurological or psychiatric disease) will be recruited into the study. The duration of the protocol is 70 minutes. As regards the assessment, three questionnaires will be administered in order to evaluate self-defining memories, apathetic manifestations and anxio-depressive symptoms. In addition, four cognitive measures will be used to assess verbal episodic memory, working memory, cognitive flexibility and verbal fluency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive measures and questionnaires | Other | Other: Questionnaires and cognitive measuresthe material of the study will consist of cognitive measures and questionnaires in order to (1) compare the cognitive performances and behavioral manifestations between patients with TBI and volunteers without neurological disorders and (2) to analyze the links between cognitive and behavioural measures in the TBI population |
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 TBI occurred at least 6 months ago (initial Glasgow Coma Scale score ≤ 12 or post-traumatic amnesia duration > 1 week)
- patients ≥ 18 years old and who have signed a letter of information
Key exclusion criteria (6 listed)
- history of neurological and/or psychiatric disease
- persistent motor, sensitive and instrumental disorders that could disturb the efficient evaluation of the participant
- 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 |
|---|---|---|
| Questionnaires and cognitive measures | Other | cognitive measures and questionnaires |
Primary outcome
self-defining memory score
Time frame: 20 minutes
self-defining memories will be measured using the self-defining memories questionnaire
6 secondary outcomes
verbal episodic memory score
Time frame: 20 minutes
working memory score
Time frame: 10 minutes
cognitive flexibility score
Time frame: 5 minutes
verbal fluency score
Time frame: 5 minutes
apathy score
Time frame: 5 minutes
anxio-depressive score
Time frame: 5 minutes
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 13 May 2019.
- 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.
Annabelle Arnould, psychologue study chair
Hôpital Raymond Poincaré
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 and cognitive measures in people with Traumatic Brain Injuries and Neurobehavioral Manifestations, 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 6 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 13 May 2019. 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?
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?
self-defining memory score (time frame: 20 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 13 May 2019.