Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Multiple Sclerosis
Recruitment status was Not yet recruiting
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 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|
- 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.
- 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
|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)|
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)
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Principal Investigator:||Murat Yildiz, MD||Cantonal Hospital Saint Gallen|