Brain IschemiaBCNNCT02819167
Brain and Cognitive Reserve
A study testing neurologic and neuropsychological evaluation in people with Brain Ischemia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Ischemic strokes are one of the leading causes of handicap and death in elderly people in France. Cognitive reserve (CR) is an active model, defined as a function of lifetime intellectual activities and other environmental factors that explain differential susceptibility to functional impairment in the presence of… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Brain Ischemia
- What is being tested?
- neurologic and neuropsychological evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2016to Aug 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥70 years old
- right middle cerebral artery ischemic stroke
- hospitalized in neurovascular unit of Pierre Wertheimer hospital between January 2015 to January 2016
Who cannot join
- Contraindication for MRI
- Hemorrhagic stroke
- Aphasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuro-anatomical Correlates on Volumetric MRI on the Impact of Brain Reserve and Cognitive Reserve on Ischemic Strokes in Elderly
Ischemic strokes are one of the leading causes of handicap and death in elderly people in France.
Cognitive reserve (CR) is an active model, defined as a function of lifetime intellectual activities and other environmental factors that explain differential susceptibility to functional impairment in the presence of pathology or other neurological insult. CR is estimated using variables for cognitive activity: years of education, professional status, socioeconomic status… Furthermore, brain reverse (BR) is a passive and quantitative model that depend on brain size and other quantitative aspects of the brain that explain differential susceptibility to functional impairment in the presence of pathology.
Read more
Firstly, volume and localization of ischemic strokes have a great impact on CR and BR due to brain injury. On the other hand, CR influences the severity and the expression of cognitive diseases.
The investigators realize a prospective study in order to assess the impact of CR and BR on cognitive prognosis after a right middle cerebral artery ischemic stroke in elderly patients.
- Conditions
- Brain Ischemia
- Being tested
- neurologic and neuropsychological evaluation
- Keywords
- ischemic stroke, brain reserve, cognitive reserve, cognitive prognosis
- Medical subject headings
- Brain Ischemia, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurologic and neuropsychological evaluationOther
cognitive prognosis, cognitive reserve, brain volume will be studied on patients with scale, questionnaire, magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| neurologic and neuropsychological evaluation | Other | Not described Receives: Other: neurologic and neuropsychological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of cognitive prognosis
measure will be performed with the Mattis dementia rating scale
Measured: one year post Ischemic stroke
Secondary outcomes (5)
Volume of leucoencephalopathy
measure will be performed with a MRI
Measured: one year post Ischemic stroke
volume of hippocampic
measure will be performed with a MRI
Measured: one year post Ischemic stroke
brain injury
measure will be performed with a MRI
Measured: one year post Ischemic stroke
volume of ischemic stroke
measure will be performed with a MRI
Measured: one year post Ischemic stroke
evaluation of cognitive reserve
measure will be performed with the Cognitive reserve index questionnaire
Measured: one year post Ischemic stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start26 May 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain IschemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Krolak Salmon, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819167
- Sponsor's protocol ID
- 69HCL16_0151
- Acronym
- BCN
- Status last verified
- Nov 2017
- First submitted
- 28 Jun 2016
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-anatomical Correlates on Volumetric MRI on the Impact of Brain Reserve and Cognitive Reserve on Ischemic Strokes in Elderly
- ClinicalTrials.gov ID
- NCT02819167
- Acronym / sponsor ID
- BCN / 69HCL16_0151
- Conditions
- Brain Ischemia
- Keywords
- ischemic stroke, brain reserve, cognitive reserve, cognitive prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 May 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Jun 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.
Ischemic strokes are one of the leading causes of handicap and death in elderly people in France.
Cognitive reserve (CR) is an active model, defined as a function of lifetime intellectual activities and other environmental factors that explain differential susceptibility to functional impairment in the presence of pathology or other neurological insult. CR is estimated using variables for cognitive activity: years of education, professional status, socioeconomic status… Furthermore, brain reverse (BR) is a passive and quantitative model that depend on brain size and other quantitative aspects of the brain that explain differential susceptibility to functional impairment in the presence of pathology.
Firstly, volume and localization of ischemic strokes have a great impact on CR and BR due to brain injury. On the other hand, CR influences the severity and the expression of cognitive diseases.
The investigators realize a prospective study in order to assess the impact of CR and BR on cognitive prognosis after a right middle cerebral artery ischemic stroke in elderly patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neurologic and neuropsychological evaluation | Other | Other: neurologic and neuropsychological evaluation |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥70 years old
- right middle cerebral artery ischemic stroke
- hospitalized in neurovascular unit of Pierre Wertheimer hospital between January 2015 to January 2016
Key exclusion criteria (3 listed)
- Contraindication for MRI
- Hemorrhagic stroke
- Aphasia
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 |
|---|---|---|
| neurologic and neuropsychological evaluationcognitive prognosis, cognitive reserve, brain volume will be studied on patients with scale, questionnaire, magnetic resonance imaging | Other | neurologic and neuropsychological evaluation |
Primary outcome
evaluation of cognitive prognosis
Time frame: one year post Ischemic stroke
measure will be performed with the Mattis dementia rating scale
5 secondary outcomes
Volume of leucoencephalopathy
Time frame: one year post Ischemic stroke
volume of hippocampic
Time frame: one year post Ischemic stroke
brain injury
Time frame: one year post Ischemic stroke
volume of ischemic stroke
Time frame: one year post Ischemic stroke
evaluation of cognitive reserve
Time frame: one year post Ischemic stroke
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 20 Nov 2017.
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Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
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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.
Pierre Krolak Salmon, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurologic and neuropsychological evaluation in people with Brain Ischemia, run by Hospices Civils de Lyon 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 3 inclusion and 3 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 20 Nov 2017. 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?
evaluation of cognitive prognosis (time frame: one year post Ischemic stroke). 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 20 Nov 2017.