Bayer/Cognitive Assessments With Multiple Sclerosis Subjects

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Multiple Sclerosis, Relapsing-remitting; Multiple Sclerosis, Secondary Progressive

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 Design

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Study Type :	Observational
Actual Enrollment :	74 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Outcome Measures :

1. SDMT association with the BDI. The SDMT will be independent of depression. [ Time Frame: 1 year ]
2. 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 ]
3. Lack of association of Cognitive Dysfunction with the Physical Scales of the EDSS. [ Time Frame: 1 year ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of Louisville

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Investigators

Principal Investigator:	Richard Kirzinger, MD	University of Louisville

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Louisville
ClinicalTrials.gov Identifier:	NCT00888277 History of Changes
Other Study ID Numbers:	UofL IRB # 09.0167; OICN 090742
First Posted:	April 27, 2009
Last Update Posted:	November 4, 2013
Last Verified:	October 2013

Additional relevant MeSH terms:

Sclerosis; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS	Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases