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Completed

NCT Number: NCT00888277

Bayer/Cognitive Assessments With Multiple Sclerosis Subjects

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Secondary Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Registry information

Official study title

Neuropsychological Assessments in the Multiple Sclerosis Clinic

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Apr 27, 2009
Registry last updated
Nov 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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