Bayer/Cognitive Assessments With Multiple Sclerosis Subjects
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|ClinicalTrials.gov Identifier: NCT00888277|
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : November 4, 2013
|Condition or disease|
|Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis, Secondary Progressive|
Seventy five randomly identified patients will be evaluated. Consenting patients will perform a Symbol Digit Modalities Test (SDMT) and have the MS Center´s standard neuropsychological assessment performed. Tests comprising the standard assessment will be the RBANS (Randolph, 1998), Multiscore Depression Inventory, Cross and Clock Drawings. The selfreported Beck Depression Inventory (BDI-II) will also be obtained. An Expanded Disability Status Scale (EDSS) will be recorded for each patient. The RBANS consists of six scales labeled (1) Immediate Memory, (2) Visuospatial/ Constructional, (3) Language, (4) Attention, (5) Delayed Memory, and (6) Total. Depression will be assessed by the BDI and the MultiScore Depression Inventory.
The SDMT will be administered using standard instructions either orally or in writing. Use of the established norms for the SDMT will be used to determine if the MS patient is demonstrating some cognitive dysfunction. Scores less than 1.0 to 1.5 standard deviations below mean are suggestive of cerebral dysfunction. The results will be controlled for age, gender, and educational level.
Additionally, the results of the 75 patient assessments will be reviewed to see the concordance between the results of the SDMT and the Neuropsychological Battery. The association of cognitive dysfunction as identified by the SDMT will be correlated with each of the six RBANS scales and other parameters of the cognitive aspects of the Battery. Statistical analysis will determine the sensitivity and specificity of the SDMT in determining abnormalities as well as an optimum cutpoint. This analysis will indicate possible cognitive problems and the need for further testing and, potentially, intervention.
|Study Type :||Observational|
|Actual Enrollment :||74 participants|
|Official Title:||Neuropsychological Assessments in the Multiple Sclerosis Clinic|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||January 2010|
- SDMT correlation with the findings on the Neuropsychological Battery. The Neuropsychological Battery will confirm that the SDMT is sensitive and specific in identifying MS patients with cognitive findings. [ Time Frame: 1 year ]
- SDMT association with the BDI. The SDMT will be independent of depression. [ Time Frame: 1 year ]
- Overlap of Depression with Cognitive Dysfunction. There will still be identified a high percentage of patients having both cognitive and depressive symptoms. [ Time Frame: 1 year ]
- Lack of association of Cognitive Dysfunction with the Physical Scales of the EDSS. [ Time Frame: 1 year ]
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): NCT00888277
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Richard Kirzinger, MD||University of Louisville|