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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01250665
• Other study ID #: CogImp01
• Status: Not yet recruiting
• Phase: N/A
• First received: November 30, 2010
• Last updated: November 30, 2010
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: November 2010
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swiss Medic
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital of Saint Gallen	Saint Gallen

Sponsors (2)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen	Bayer

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Primary	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.		No
Secondary	Corpus callosum Index at baseline	The CCI at baseline will be measured from MRI findings acquired at diagnosis of clinically isolated syndrome.		No
Secondary	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).		No
Secondary	The Symbol Digit Modalities Test (SDMT)	SDMT is an easily administered brief cognitive performance tests. This test emphasizes working memory and speed processing.		No
Secondary	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		No