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Bayer/Cognitive Assessments With Multiple Sclerosis Subjects

This study has been completed.
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00888277
First received: April 22, 2009
Last updated: October 31, 2013
Last verified: October 2013
History of Changes
  Purpose
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
Multiple Sclerosis, Relapsing-remitting
Multiple Sclerosis, Secondary Progressive

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neuropsychological Assessments in the Multiple Sclerosis Clinic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SDMT association with the BDI. The SDMT will be independent of depression. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Lack of association of Cognitive Dysfunction with the Physical Scales of the EDSS. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Enrollment: 74
Study Start Date: May 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888277

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

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00888277     History of Changes
Other Study ID Numbers: UofL IRB # 09.0167  OICN 090742 
Study First Received: April 22, 2009
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 28, 2016