- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01904799
Cognitive Assessment for Stroke Patients: Reproductibility and Validity Study (Casper)
After a CVA, all of the cognitive functions can be affected and analysed, but the presence of a language disorder may considerably hamper the evaluation of other functions.
The battery of rapid tests to screen for and quantify cognitive disorders, including the MMSE, the MOCA, the R-CAMCOG or the RBANS, are not suitable for aphasic patients because they contain items with a strictly verbal response. Because of this, inexperienced doctors cannot evaluate higher functions (other than language) of aphasics in routine practice. For the same reason, aphasics are regularly excluded from post-cva therapeutic protocols, whether or not the trial bears on the evolution of cognitive functions.
Nonetheless, it is possible to evaluate, at least roughly, all of the cognitive functions without resorting to language.
The investigator have developed , from validated tests and classical clinical manoeuvers, the Cognitive Assessment for Stroke Patients (CASP) :
- for the rapid screening (less than 15 minutes) and quantification of post-cva cognitive disorders (6 functions: language, apraxia, short-term memory, temporal orientation, impaired spatial/visio-construction and executive functions);
- the CASP can be used in most patients, including those with severe disorders of expression and moderate problems with comprehension, The format of these tests has been adapted so that severe disorders of expression (essentially left-hemisphere CVA), and left spatial impairment (right-hemisphere CVA) do not affect the ability to take the test. Its validity in terms of appearance and content were verified in 2011.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Dijon, France, 21079
- CHU de Dijon
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
For CVA patients
- patients hospitalised in rehabilitation after a first recent hemispheric CVA (less than 6 weeks) ;
- aged > 18;
- absence of severe disorders of oral comprehension (BDAE aphasia severity score >2 for comprehension);
- whatever the severity of oral expression disorders;
- who have been given clear written and oral information, and after the doctor has verified their ability to understand the protocol.
For " Control " patients (to evaluate divergent validity)
- patients hospitalised in rehabilitation units or geriatrics taking part in this study;
- aged > 18.
Exclusion Criteria:
For CVA patients
- patients who do not speak French;
- cognitive disorders known before the CVA;
- psychotic disorders known before the CVA;
- major visual disorders incompatible with reading, known before the CVA.
For " Control " patients (to evaluate divergent validity)
- patients who do not speak French;
- cognitive disorders known before the CVA;
- psychotic disorders known before the CVA;
- major visual disorders incompatible with reading, known before the CVA.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Cognitive Assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
comprehensive assessment battery of higher functions
Time Frame: baseline
|
baseline
|
|
comprehensive assessment battery of higher functions
Time Frame: Evaluation at 3 ±1 days
|
Evaluation at 3 ±1 days
|
|
comprehensive assessment battery of higher functions
Time Frame: Evaluation at 6 ± 2 weeks
|
Evaluation at 6 ± 2 weeks
|
|
test of visual memory
Time Frame: baseline
|
baseline
|
|
test of visual memory
Time Frame: Evaluation at 3 ±1 days
|
Evaluation at 3 ±1 days
|
|
test of visual memory
Time Frame: Evaluation at 6 ± 2 weeks
|
Evaluation at 6 ± 2 weeks
|
Collaborators and Investigators
Publications and helpful links
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 (Estimated)
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
- Benaim PHRC N 2012
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