- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02819167
Brain and Cognitive Reserve (BCN)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France
- Hopital des Charpennes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥70 years old
- right middle cerebral artery ischemic stroke
- hospitalized in neurovascular unit of Pierre Wertheimer hospital between January 2015 to January 2016
Exclusion Criteria:
- Contraindication for MRI
- Hemorrhagic stroke
- Aphasia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: neurologic and neuropsychological evaluation
|
cognitive prognosis, cognitive reserve, brain volume will be studied on patients with scale, questionnaire, magnetic resonance imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluation of cognitive prognosis
Time Frame: one year post Ischemic stroke
|
measure will be performed with the Mattis dementia rating scale
|
one year post Ischemic stroke
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Volume of leucoencephalopathy
Time Frame: one year post Ischemic stroke
|
measure will be performed with a MRI
|
one year post Ischemic stroke
|
|
volume of hippocampic
Time Frame: one year post Ischemic stroke
|
measure will be performed with a MRI
|
one year post Ischemic stroke
|
|
brain injury
Time Frame: one year post Ischemic stroke
|
measure will be performed with a MRI
|
one year post Ischemic stroke
|
|
volume of ischemic stroke
Time Frame: one year post Ischemic stroke
|
measure will be performed with a MRI
|
one year post Ischemic stroke
|
|
evaluation of cognitive reserve
Time Frame: one year post Ischemic stroke
|
measure will be performed with the Cognitive reserve index questionnaire
|
one year post Ischemic stroke
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre Krolak Salmon, MD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0151
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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