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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis Cognitive Impairment

Keywords

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multiple sclerosis cognitive impairment interferon-beta 1b corpus callosum index

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

No interventions assigned to this group

remitting, relapsing MS

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Cantonal Hospital Saint Gallen

Principal Investigators

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Murat Yildiz, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital Saint Gallen

Locations

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Cantonal Hospital of Saint Gallen

Sankt Gallen, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED

PMID: 25459243 (View on PubMed)

Other Identifiers

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CogImp01

Identifier Type: -

Identifier Source: org_study_id