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Multimodal Evoked potentials (mmEP) reflect disease course of multiple sclerosis (MS) and are potentially suited as a biomarker for disease progression.
The acquisition of evoked potentials (EP) in this observatory trial is to evaluate the feasibility and test-retest reliability of motor and somato-sensory EP (MEP and SSEP) in an international multicenter setting in healthy subjects and subjects with multiple sclerosis (MS).
Multimodal EP (mmEP) is being developed as a predictive biomarker to determine the clinical response to therapy. MEP and SSEP contributes significantly to the predictive value of mmEP. The variability of MEP and SSEP has limited its use in multicenter clinical trials. Recent technological advances and standardization of procedures has decreased the variability. The objective of this study is to evaluate the reliability of MEP and SSEP and feasibility of performing MEP and SSEP in an international, multicenter setting. Establishment of the reliability and feasibility of MEP and SSEP will allow for further development of this predictive biomarker in future clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multiple sclerosis patients |
| ||
| healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acquisition of MEP und SSEP | Procedure | Acquisition of MEP und SSEP at two different time points within 1 to 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| intraclass correlation coefficient (ICC) of MEP and SSEP | The primary analysis will be a descriptive statistical summary of MEP and SSEP results at the first session, the second session and overall. Intraclass correlation coefficients (ICC) will be calculated to assess the test-retest reliability between consecutive measurements and the interrater reliability between raters. | time between Visit 1 (= Baseline = Day 0) and Visit 2 (= 1 day to 30 days after Visit 1) |
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Inclusion Criteria (Healthy controls):
Inclusion Criteria (Patients with MS):
Exclusion Criteria:
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Patients with MS will be recruited from the outpatient clinic at the University Hospital Basel as consecutive ongoing recruitment through project leader and Co-workers in daily clinical practice.
Healthy subjects will be recruited by bulletin on notice-boards in the hospital
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| Name | Affiliation | Role |
|---|---|---|
| Peter Fuhr, Prof. Dr. MD | University Hospital Basel; Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Neurology, Hospital of the University of Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |