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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01250665
Recruitment Status : Unknown
Verified November 2010 by Cantonal Hospital of St. Gallen.
Recruitment status was:  Not yet recruiting
First Posted : December 1, 2010
Last Update Posted : December 1, 2010
Information provided by:
Cantonal Hospital of St. Gallen

Brief Summary:
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 or disease
Multiple Sclerosis Cognitive Impairment

Study Type : Observational
Estimated Enrollment : 65 participants
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
Study Start Date : January 2011
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. Corpus callosum Index at baseline
    The CCI at baseline will be measured from MRI findings acquired at diagnosis of clinically isolated syndrome.

  2. 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).

  3. The Symbol Digit Modalities Test (SDMT)
    SDMT is an easily administered brief cognitive performance tests. This test emphasizes working memory and speed processing.

  4. 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

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01250665

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
Principal Investigator: Murat Yildiz, MD Cantonal Hospital Saint Gallen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Murat Yildiz, Cantonal Hospital Saint Gallen Identifier: NCT01250665     History of Changes
Other Study ID Numbers: CogImp01
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010

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

Additional relevant MeSH terms:
Multiple Sclerosis
Cognitive Dysfunction
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
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Pathological Conditions, Anatomical