Bayer/Cognitive Assessments With Multiple Sclerosis Subjects

Multiple Sclerosis, Relapsing-remitting Clinical Trial

Official title:

Neuropsychological Assessments in the Multiple Sclerosis Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888277
• Other study ID #: UofL IRB # 09.0167
• Secondary ID: OICN 090742
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: October 31, 2013
• Start date: May 2009
• Est. completion date: January 2010

Study information

• Verified date: October 2013
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis, Secondary Progressive
• Sclerosis

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	No
Secondary	SDMT association with the BDI. The SDMT will be independent of depression.		1 year	No
Secondary	Overlap of Depression with Cognitive Dysfunction. There will still be identified a high percentage of patients having both cognitive and depressive symptoms.		1 year	No
Secondary	Lack of association of Cognitive Dysfunction with the Physical Scales of the EDSS.		1 year	No