NCT00888277

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

November 4, 2013

Status Verified

October 1, 2013

Enrollment Period

7 months

First QC Date

April 22, 2009

Last Update Submit

October 31, 2013

Conditions

Multiple Sclerosis, Relapsing-remittingMultiple Sclerosis, Secondary Progressive

Outcome Measures

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.

    1 year

Secondary Outcomes (3)

  • SDMT association with the BDI. The SDMT will be independent of depression.

    1 year

  • Overlap of Depression with Cognitive Dysfunction. There will still be identified a high percentage of patients having both cognitive and depressive symptoms.

    1 year

  • Lack of association of Cognitive Dysfunction with the Physical Scales of the EDSS.

    1 year

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from patients diagnosed with MS at the University of Louisville Neurologists PCS.

You may qualify if:

  • EDSS at last visit ≤ 7.0
  • Relapsing/Remitting or Secondary Progressive MS

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Kirzinger, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 27, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

November 4, 2013

Record last verified: 2013-10

Locations

US(1)