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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01904799
First received: July 12, 2013
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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 Intervention
Stroke
Other: Cognitive Assessment test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • comprehensive assessment battery of higher functions [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • comprehensive assessment battery of higher functions [ Time Frame: Evaluation at 3 ±1 days ] [ Designated as safety issue: No ]
  • comprehensive assessment battery of higher functions [ Time Frame: Evaluation at 6 ± 2 weeks ] [ Designated as safety issue: No ]
  • test of visual memory [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • test of visual memory [ Time Frame: Evaluation at 3 ±1 days ] [ Designated as safety issue: No ]
  • test of visual memory [ Time Frame: Evaluation at 6 ± 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 290
Study Start Date: September 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cognitive Assessment Other: Cognitive Assessment test

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria for CVA patients
  • patients hospitalised in neurology or in rehabilitation after a first recent hemispheric CVA (less than 6 weeks) ;
  • aged 18 to 80 years;
  • 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.

" Control " patients in orthopedic rehabilitation (to evaluate divergent validity)

  • patients hospitalised in one of the orthopedic rehabilitation units taking part in this study;
  • aged from 18 to 80 years.

Exclusion Criteria:

  • 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. " Control " patients in orthopedic rehabilitation (to evaluate divergent validity)

Inclusion criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904799

Locations
France
CHU de Dijon Not yet recruiting
Dijon, France, 21079
Contact: Maud CARPENTIER    03.80.29.35.10    maud.carpentier@chu-dijon.fr   
Principal Investigator: Charles Benaim         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01904799     History of Changes
Other Study ID Numbers: Benaim PHRC N 2012
Study First Received: July 12, 2013
Last Updated: July 17, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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

ClinicalTrials.gov processed this record on August 01, 2014