Bayer/Cognitive Assessments With Multiple Sclerosis Subjects

NCT ID: NCT00888277

Last Updated: 2013-11-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-01-31

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.

Conditions

Multiple Sclerosis, Relapsing-remitting; Multiple Sclerosis, Secondary Progressive

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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 > 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Kirzinger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

OICN 090742

Identifier Type: -

Identifier Source: secondary_id

UofL IRB # 09.0167

Identifier Type: -

Identifier Source: org_study_id