Cerebrovascular AccidentMEMOIRE ET EMONCT02887105
Memory and Emotion in Acute and Chronic Phases of Cerebrovascular Accident
An observational study of Cerebrovascular Accident, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
The purpose is to determine the relationship between anxiety and cognitive performances in patients with acute and chronic phases of cerebrovascular accident (CVA). Data from neuropsychological assessment concerning cognitive processes (working and episodic memory) sensitive to different dimensions of anxiety will be… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Standard neuropsychological assessment and Brain MRI
- How many people
- 76 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2012to Apr 2014
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for a cerebrovascular accident
Who may be able to join
- Acute phase of carotid, vertebrobasilar or lacunar cerebrovascular accident with ischemic or hemorrhagic origin
- Right-handed
- Possible cooperation: understanding of French instructions
- Normal or corrected vision
- Normal or corrected hearing
- Mini-mental state examination score higher than pathologic threshold according to age and sociocultural level of patient
- Possible follow up of patient
Who cannot join
- Hearing problems
- Vision problems
- Right hemiplegia or acute monoparesis of right upper limb
- Hemispatial neglect
- Apraxia
- Psychiatric or neurological history possibly interfering with neuropsychological evaluation
- Important defect of working memory or executive functions
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Neurologie - Hôpital Bon Secours - CHR de Metz-Thionville
Metz
Service de Neurologie - Hôpital Central - CHU de Nancy
Nancy
About this study
The purpose is to determine the relationship between anxiety and cognitive performances in patients with acute and chronic phases of cerebrovascular accident (CVA). Data from neuropsychological assessment concerning cognitive processes (working and episodic memory) sensitive to different dimensions of anxiety will be analyzed.
The secondary purpose is to evaluate how some neurological (hemispherical lateralization of lesions), psychological (depression) and demographic (quality of life) variables can increase the effects of different dimensions of anxiety on cognitive processes, during the acute and/or chronic phase of CVA.
Read the detailed description
Data will be collected during usual neuropsychological evaluation and cerebral imagery examination (NIHSS, Rankin scale) of patients in acute (0-1 month) and chronic (6 months) phases of CVA.
- Conditions
- Cerebrovascular Accident
- Being tested
- Standard neuropsychological assessment, Brain MRI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard neuropsychological assessmentOther
Brain MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with cerebrovascular accident | Not described Receives: Other: Standard neuropsychological assessment; Other: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
State of anxiety evaluated with STAI-YA scale
Measured: up to 1 month (from CVA)
State of anxiety evaluated with STAI-YA scale
Measured: 6 months (from CVA)
Anxiety proneness evaluated with STAI-YB scale
Measured: up to 1 month (from CVA)
Anxiety proneness evaluated with STAI-YB scale
Measured: 6 months (from CVA)
Apprehension anxiety evaluated with Penn State Worry Questionnaire
Measured: up to 1 month (from CVA)
Apprehension anxiety evaluated with Penn State Worry Questionnaire
Measured: 6 months (from CVA)
Evaluation of working memory updating with N-back verbal and visuospatial task
Measured: up to 1 month (from CVA)
Evaluation of working memory updating with N-back verbal and visuospatial task
Measured: 6 months (from CVA)
Evaluation of working memory inhibition with Stimulus-response compatibility task
Measured: up to 1 month (from CVA)
Evaluation of working memory inhibition with Stimulus-response compatibility task
Measured: 6 months (from CVA)
Evaluation of working memory flexibility with Switching task
Measured: up to 1 month (from CVA)
Evaluation of working memory flexibility with Switching task
Measured: 6 months (from CVA)
Evaluation of verbal working memory with Wechsler memory scale
Measured: up to 1 month (from CVA)
Evaluation of verbal working memory with Wechsler memory scale
Measured: 6 months (from CVA)
Evaluation of visuospatial working memory with Wechsler memory scale
Measured: up to 1 month (from CVA)
Evaluation of visuospatial working memory with Wechsler memory scale
Measured: 6 months (from CVA)
Evaluation of visual episodic memory with Rey and Taylor figure test
Measured: 6 months (from CVA)
Evaluation of verbal episodic memory with RL/RI 16 item test
Measured: 6 months (from CVA)
Secondary outcomes (4)
Hemispheric lateralization of lesions detected with MRI
Measured: up to 1 month from CVA
Depression state evaluated with Back depression inventory
Measured: up to 1 month (from CVA)
Depression state evaluated with Back depression inventory
Measured: 6 months (from CVA)
Quality of life evaluated with SF-36 test
Measured: after 6 months from CVA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startDec 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier DUCROCQ, Pr, Principal investigator, Service de Neurologie - Unité Neurovasculaire - Hôpital Central Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887105
- Sponsor's protocol ID
- PSS2012/MEMOIRE-DUCROCQ/MS
- Acronym
- MEMOIRE ET EMO
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory and Emotion in Acute and Chronic Phases of Cerebrovascular Accident
- ClinicalTrials.gov ID
- NCT02887105
- Acronym / sponsor ID
- MEMOIRE ET EMO / PSS2012/MEMOIRE-DUCROCQ/MS
- Conditions
- Cerebrovascular Accident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Sep 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 purpose is to determine the relationship between anxiety and cognitive performances in patients with acute and chronic phases of cerebrovascular accident (CVA). Data from neuropsychological assessment concerning cognitive processes (working and episodic memory) sensitive to different dimensions of anxiety will be analyzed.
The secondary purpose is to evaluate how some neurological (hemispherical lateralization of lesions), psychological (depression) and demographic (quality of life) variables can increase the effects of different dimensions of anxiety on cognitive processes, during the acute and/or chronic phase of CVA.
Detailed description
Data will be collected during usual neuropsychological evaluation and cerebral imagery examination (NIHSS, Rankin scale) of patients in acute (0-1 month) and chronic (6 months) phases of CVA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cerebrovascular accident | – | Other: Standard neuropsychological assessment, Other: Brain MRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for a cerebrovascular accident
Key inclusion criteria (7 listed)
- Acute phase of carotid, vertebrobasilar or lacunar cerebrovascular accident with ischemic or hemorrhagic origin
- Right-handed
- Possible cooperation: understanding of French instructions
- Normal or corrected vision
- Normal or corrected hearing
Key exclusion criteria (7 listed)
- Hearing problems
- Vision problems
- Right hemiplegia or acute monoparesis of right upper limb
- Hemispatial neglect
- Apraxia
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 |
|---|---|---|
| Standard neuropsychological assessment | Other | Patients with cerebrovascular accident |
| Brain MRI | Other | Patients with cerebrovascular accident |
Primary outcome
State of anxiety evaluated with STAI-YA scale
Time frame: up to 1 month (from CVA)
State of anxiety evaluated with STAI-YA scale
Time frame: 6 months (from CVA)
Anxiety proneness evaluated with STAI-YB scale
Time frame: up to 1 month (from CVA)
Anxiety proneness evaluated with STAI-YB scale
Time frame: 6 months (from CVA)
Apprehension anxiety evaluated with Penn State Worry Questionnaire
Time frame: up to 1 month (from CVA)
Apprehension anxiety evaluated with Penn State Worry Questionnaire
Time frame: 6 months (from CVA)
Evaluation of working memory updating with N-back verbal and visuospatial task
Time frame: up to 1 month (from CVA)
Evaluation of working memory updating with N-back verbal and visuospatial task
Time frame: 6 months (from CVA)
Evaluation of working memory inhibition with Stimulus-response compatibility task
Time frame: up to 1 month (from CVA)
Evaluation of working memory inhibition with Stimulus-response compatibility task
Time frame: 6 months (from CVA)
Evaluation of working memory flexibility with Switching task
Time frame: up to 1 month (from CVA)
Evaluation of working memory flexibility with Switching task
Time frame: 6 months (from CVA)
Evaluation of verbal working memory with Wechsler memory scale
Time frame: up to 1 month (from CVA)
Evaluation of verbal working memory with Wechsler memory scale
Time frame: 6 months (from CVA)
Evaluation of visuospatial working memory with Wechsler memory scale
Time frame: up to 1 month (from CVA)
Evaluation of visuospatial working memory with Wechsler memory scale
Time frame: 6 months (from CVA)
Evaluation of visual episodic memory with Rey and Taylor figure test
Time frame: 6 months (from CVA)
Evaluation of verbal episodic memory with RL/RI 16 item test
Time frame: 6 months (from CVA)
4 secondary outcomes
Hemispheric lateralization of lesions detected with MRI
Time frame: up to 1 month from CVA
Depression state evaluated with Back depression inventory
Time frame: up to 1 month (from CVA)
Depression state evaluated with Back depression inventory
Time frame: 6 months (from CVA)
Quality of life evaluated with SF-36 test
Time frame: after 6 months from CVA
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 8 Sep 2016.
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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.
Xavier DUCROCQ, Pr principal investigator
Service de Neurologie - Unité Neurovasculaire - Hôpital Central Nancy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident, run by Central Hospital, Nancy, France at 2 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 7 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: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
State of anxiety evaluated with STAI-YA scale (time frame: up to 1 month (from CVA)). The study lists 18 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 8 Sep 2016.