Bayer/Cognitive Assessments With Multiple Sclerosis Subjects
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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 |
- 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 ]
- 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 ]
| Estimated Enrollment: | 75 |
| Study Start Date: | May 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Subjects will be recruited from patients diagnosed with MS at the University of Louisville Neurologists PCS.
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| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| Principal Investigator: | Richard Kirzinger, MD | University of Louisville |
More Information
No publications provided
| Responsible Party: | Stephen Kirzinger, 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: | February 19, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting 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 May 16, 2013