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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Cantonal Hospital of St. Gallen.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01250665
First received: November 30, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition
Multiple Sclerosis
Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cohort Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Early and Remitting Relapsing Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Multiple Sclerosis Inventory Cognition (MUSIC) [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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:
  • Corpus callosum Index at baseline [ Designated as safety issue: No ]
    The CCI at baseline will be measured from MRI findings acquired at diagnosis of clinically isolated syndrome.

  • Time to clinically definite MS [ Designated as safety issue: No ]
    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) [ Designated as safety issue: No ]
    SDMT is an easily administered brief cognitive performance tests. This test emphasizes working memory and speed processing.

  • Ratio treatment duration to disease duration [ Designated as safety issue: No ]
    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


Estimated Enrollment: 65
Study Start Date: January 2011
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250665

Locations
Switzerland
Cantonal Hospital of Saint Gallen Not yet recruiting
Saint Gallen, Switzerland, 9007
Principal Investigator: Murat Yildiz, MD         
Sub-Investigator: Stafanie Muller, MD         
Sub-Investigator: Jochen Vehoff, MD         
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Bayer
Investigators
Principal Investigator: Murat Yildiz, MD Cantonal Hospital Saint Gallen
  More Information

No publications provided

Responsible Party: Murat Yildiz, Cantonal Hospital Saint Gallen
ClinicalTrials.gov Identifier: NCT01250665     History of Changes
Other Study ID Numbers: CogImp01
Study First Received: November 30, 2010
Last Updated: November 30, 2010
Health Authority: Switzerland: Swiss Medic

Keywords provided by Cantonal Hospital of St. Gallen:
multiple sclerosis
cognitive impairment
interferon-beta 1b
corpus callosum index

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Cognition Disorders
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 16, 2014