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Cognitive Assessment for Stroke Patients: Reproductibility and Validity Study (Casper)

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ClinicalTrials.gov Identifier: NCT01904799
Recruitment Status : Recruiting
First Posted : July 22, 2013
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Stroke Other: Cognitive Assessment test Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Study Start Date : December 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Cognitive Assessment Other: Cognitive Assessment test



Primary Outcome Measures :
  1. comprehensive assessment battery of higher functions [ Time Frame: baseline ]
  2. comprehensive assessment battery of higher functions [ Time Frame: Evaluation at 3 ±1 days ]
  3. comprehensive assessment battery of higher functions [ Time Frame: Evaluation at 6 ± 2 weeks ]
  4. test of visual memory [ Time Frame: baseline ]
  5. test of visual memory [ Time Frame: Evaluation at 3 ±1 days ]
  6. test of visual memory [ Time Frame: Evaluation at 6 ± 2 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904799


Locations
France
CHU de Dijon Recruiting
Dijon, France, 21079
Contact: Charles BENAIM       charles.benaim@chu-dijon.fr   
Principal Investigator: Charles Benaim         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01904799     History of Changes
Other Study ID Numbers: Benaim PHRC N 2012
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases