Clinical trial NCT01250665: Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Multiple Sclerosis
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Cognitive Impairment
Keywords: multiple sclerosis
cognitive impairment
interferon-beta 1b
corpus callosum index
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2010-12-01
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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

Primary outcomes:
measure: Multiple Sclerosis Inventory Cognition (MUSIC)
measure: Annual Corpus Callosum Index decrease
Secondary outcomes:
measure: Corpus callosum Index at baseline
measure: Time to clinically definite MS
measure: The Symbol Digit Modalities Test (SDMT)
measure: Ratio treatment duration to disease duration
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Cantonal Hospital of Saint Gallen
Study officials:
affiliation: Cantonal Hospital Saint Gallen
name: Murat Yildiz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yildiz M, Tettenborn B, Radue EW, Bendfeldt K, Borgwardt S. Association of cognitive impairment and lesion volumes in multiple sclerosis--a MRI study. Clin Neurol Neurosurg. 2014 Dec;127:54-8. doi: 10.1016/j.clineuro.2014.09.019. Epub 2014 Oct 14.