Bayer/Cognitive Assessments With Multiple Sclerosis Subjects

Neuropsychological Assessments in the Multiple Sclerosis Clinic

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Relapsing-remitting

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.

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from patients diagnosed with MS at the University of Louisville Neurologists PCS.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Severe Depressive Illness: Beck Depression Inventory Score > 55.
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Lack of association of Cognitive Dysfunction with the Physical Scales of the EDSS.	1 year

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
• Investigators: Principal Investigator: Richard Kirzinger, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: April 24, 2009
• First Posted (Estimate): April 27, 2009

Study Record Updates

• Last Update Posted (Estimate): November 3, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: UofL IRB # 09.0167; OICN 090742