Brain and Cognitive Reserve (BCN)
Primary Purpose
Brain Ischemia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
neurologic and neuropsychological evaluation
Sponsored by
About this trial
This is an interventional basic science trial for Brain Ischemia focused on measuring ischemic stroke, brain reserve, cognitive reserve, cognitive prognosis
Eligibility Criteria
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
Sites / Locations
- Hôpital des Charpennes
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
neurologic and neuropsychological evaluation
Arm Description
Outcomes
Primary Outcome Measures
evaluation of cognitive prognosis
measure will be performed with the Mattis dementia rating scale
Secondary Outcome Measures
Volume of leucoencephalopathy
measure will be performed with a MRI
volume of hippocampic
measure will be performed with a MRI
brain injury
measure will be performed with a MRI
volume of ischemic stroke
measure will be performed with a MRI
evaluation of cognitive reserve
measure will be performed with the Cognitive reserve index questionnaire
Full Information
NCT ID
NCT02819167
First Posted
June 28, 2016
Last Updated
November 16, 2017
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02819167
Brief Title
Brain and Cognitive Reserve
Acronym
BCN
Official Title
Neuro-anatomical Correlates on Volumetric MRI on the Impact of Brain Reserve and Cognitive Reserve on Ischemic Strokes in Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 26, 2016 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Ischemia
Keywords
ischemic stroke, brain reserve, cognitive reserve, cognitive prognosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
neurologic and neuropsychological evaluation
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
neurologic and neuropsychological evaluation
Intervention Description
cognitive prognosis, cognitive reserve, brain volume will be studied on patients with scale, questionnaire, magnetic resonance imaging
Primary Outcome Measure Information:
Title
evaluation of cognitive prognosis
Description
measure will be performed with the Mattis dementia rating scale
Time Frame
one year post Ischemic stroke
Secondary Outcome Measure Information:
Title
Volume of leucoencephalopathy
Description
measure will be performed with a MRI
Time Frame
one year post Ischemic stroke
Title
volume of hippocampic
Description
measure will be performed with a MRI
Time Frame
one year post Ischemic stroke
Title
brain injury
Description
measure will be performed with a MRI
Time Frame
one year post Ischemic stroke
Title
volume of ischemic stroke
Description
measure will be performed with a MRI
Time Frame
one year post Ischemic stroke
Title
evaluation of cognitive reserve
Description
measure will be performed with the Cognitive reserve index questionnaire
Time Frame
one year post Ischemic stroke
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Krolak Salmon, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital des Charpennes
City
Lyon
Country
France
12. IPD Sharing Statement
Learn more about this trial
Brain and Cognitive Reserve
We'll reach out to this number within 24 hrs