Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT02861014 - A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) Phase 3
Terminated NCT01435993 - Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis Phase 1
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Completed NCT02410200 - Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS Phase 2
Completed NCT03975413 - Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis
Completed NCT05080270 - Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis Early Phase 1
Completed NCT01116427 - A Cooperative Clinical Study of Abatacept in Multiple Sclerosis Phase 2
Completed NCT01108887 - An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmartâ„¢. N/A
Completed NCT01141751 - An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif® Therapy N/A
Completed NCT00097331 - Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis Phase 2
Completed NCT01909492 - Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
Completed NCT04121221 - A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS Phase 3
Withdrawn NCT04880577 - Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis Phase 2
Not yet recruiting NCT05290688 - Cellular microRNA Signatures in Multiple Sclerosis N/A
Completed NCT04528121 - Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis N/A
Recruiting NCT04002934 - Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis Phase 2
Recruiting NCT05019248 - Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine
Completed NCT04580381 - Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort
Completed NCT00071838 - Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis Phase 2