Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Multiple Sclerosis

November 30, 2010 updated by: Cantonal Hospital of St. Gallen

Cohort Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Early and Remitting Relapsing Multiple Sclerosis

This study is a cross sectional study of patients diagnosed with clinically isolated syndrome (CIS) and RRMS, who will undergo a series of tests to assess cognitive impairment, fatigue severity and depressive symptoms. Cognitive impairment will be assessed with Multiple Sclerosis Inventory Cognition (MUSIC) and symbol digit modalities test (SDMT), fatigue severity will be measured with the Fatigue Scale for Motor and Cognitive Functions (FSMC) and depressive symptoms with the Beck Depression Inventory (BDI). All tests mentioned above are validated for MS patients. In the second step we will use our large longitudinal database of serial MRI examinations from which a linear measurement of CCI will be retrospectively calculated.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Saint Gallen, Switzerland, 9007
        • Cantonal Hospital of Saint Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

MS-Patients will be recruited in the outpatient clinic of the neurology department of the cantonal hospital of Saint Gallen, responsible for treatment of MS patients of Northeast Switzerland.

Description

Inclusion Criteria:

  • Patients between 18 and 55 years at presentation
  • Diagnosis of relapsing-remitting MS according to revised McDonald criteria 2005, clinically isolated syndrome suggestive of MS
  • Patients treated with interferon-beta 1b
  • Untreated patients
  • EDSS under 5.5

Exclusion Criteria:

  • Brain pathology other than MS
  • Known history of head trauma
  • Pure spinal manifestation of demyelization
  • Neuromyelitis optica
  • Primary and secondary progressive MS
  • Benzodiazepine intake within the last three months
  • Relapse within the last three months
  • Steroid intake within the last three months
  • History of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse
  • No informed consent
  • Insufficient knowledge of German

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
clinically isolated syndrome
In this study the term clinically isolated syndrome (CIS) is defined according to the Task Force on Differential Diagnosis in MS, as a monophasic presentation of neurological symptoms with suspected underlying inflammatory demyelinating disease (Miller 2008).
remitting, relapsing MS
remitting relapsing MS according to the criteria by Poser (Poser 1983) or McDonald (McDonald 2001)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Multiple Sclerosis Inventory Cognition (MUSIC)
MUSIC is a cognitive screening instrument. It assesses the cognitive core deficit in MS (mental flexibility, attention, information processing speed, memory and inhibitory control) and includes 3 items derived from a factorial analysis to examine cognitive, motor and psychosocial fatigue, respectively.
Annual Corpus Callosum Index decrease
Corpus callosum index (CCI) is an easy to use MRI marker for estimating brain atrophy in patients with MS. Demonstrated correlation of CCI and atrophy has been measured with brain parenchymal fraction.

Secondary Outcome Measures

Outcome Measure
Measure Description
Corpus callosum Index at baseline
The CCI at baseline will be measured from MRI findings acquired at diagnosis of clinically isolated syndrome.
Time to clinically definite MS
This is the time in months then patients diagnosed with CIS go on to develop clinically definite MS (CDMS). CDMS will be diagnosed if patients fulfill the criteria for remitting relapsing MS according to Poser (Poser 1983) or McDonald (McDonald 2001).
The Symbol Digit Modalities Test (SDMT)
SDMT is an easily administered brief cognitive performance tests. This test emphasizes working memory and speed processing.
Ratio treatment duration to disease duration
The ratio of duration of treatment (DT) to duration of disease (DD): DT/DD. Duration of treatment is the cumulative time of treatment with interferon-beta 1b. Duration of disease starts from the first presentation of MS symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Collaborators

Bayer

Investigators

  • Principal Investigator: Murat Yildiz, MD, Cantonal Hospital Saint Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

November 30, 2010

First Submitted That Met QC Criteria

November 30, 2010

First Posted (Estimate)

December 1, 2010

Study Record Updates

Last Update Posted (Estimate)

December 1, 2010

Last Update Submitted That Met QC Criteria

November 30, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CogImp01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe