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Clinical Trials/NCT00888277
NCT00888277
Completed
Not Applicable

Neuropsychological Assessments in the Multiple Sclerosis Clinic

University of Louisville1 site in 1 country74 target enrollmentMay 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis, Relapsing-remitting
Sponsor
University of Louisville
Enrollment
74
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This study is designed to identify a brief screening evaluation for MS patients that is sensitive and specific to the MS population and which correlates with the findings of our standard-of-care neuropsychological assessments.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
January 2010
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • EDSS at last visit ≤ 7.0
  • Relapsing/Remitting or Secondary Progressive MS

Exclusion Criteria

  • Severe Depressive Illness: Beck Depression Inventory Score \>
  • Unable to read with/without glasses- Visual Acuity better than or equal to 20/60 in one eye.
  • Unwilling to sign Informed Consent.
  • Evidence on clinical examination of severe dementia at discretion of evaluating neurologist.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Lack of association of Cognitive Dysfunction with the Physical Scales of the EDSS.(1 year)
  • SDMT association with the BDI. The SDMT will be independent of depression.(1 year)
  • Overlap of Depression with Cognitive Dysfunction. There will still be identified a high percentage of patients having both cognitive and depressive symptoms.(1 year)

Study Sites (1)

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