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

Cantonal Hospital of St. Gallen

Status: Unknown

Conditions: Cognitive Impairment; Multiple Sclerosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01250665

CogImp01

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

65 participants in 2 patient groups

clinically isolated syndrome

Description:

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

Description:

remitting relapsing MS according to the criteria by Poser (Poser 1983) or McDonald (McDonald 2001)