Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Multiple Sclerosis
|ClinicalTrials.gov 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
|Condition or disease|
|Multiple Sclerosis Cognitive Impairment|
|Study Type :||Observational|
|Estimated Enrollment :||65 participants|
|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|
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)
- 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 decreaseCorpus 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 baselineThe CCI at baseline will be measured from MRI findings acquired at diagnosis of clinically isolated syndrome.
- Time to clinically definite MSThis 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 durationThe 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
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||Murat Yildiz, MD||Cantonal Hospital Saint Gallen|