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Utility of Multimodal Evoked potentials (mmEP) for monitoring disease course and prediction of progression at different stages of Multiple Sclerosis (MS) is investigated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clinically isolated syndrome (CIS) | Multiple sclerosis (MS) with a clinically isolated syndrome (CIS) within six months of first clinical event. Multimodal evoked potentials (mmEP) assessments will take place at baseline, month 12 (from baseline), month 24 (from baseline) and month 36 (from baseline) |
| |
| early relapsing-remitting late disease course (RRMS) | MS with relapsing-remitting early disease course (RRMS) \ |
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| late relapsing-remitting late disease course (RRMS) | MS with relapsing-remitting late disease course (late RRMS) of 5 to 15 years, EDSS: 2.0-5.5 inclusive EDSS: 4.0: Significant disability but self-sufficient and up and about some 12 hours a day. Able to walk without aid or rest for 500m 4.5: Significant disability but up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance. Able to walk without aid or rest for 300m 5.0: Disability severe enough to impair full daily activities and ability to work a full day without special provisions. Able to walk without aid or rest for 200m 5.5: Disability severe enough to preclude full daily activities. Able to walk without aid or rest for 100m. Multimodal evoked potentials (mmEP) assessments will take place at baseline, month 12 (from baseline), month 24 (from baseline) and month 36 (from baseline) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multimodal evoked potentials (mmEP) | Diagnostic Test | combination of visual evoked potentials (VEP) and motor evoked potentials (MEP) or the combination of VEP, MEP and somato-sensory evoked potentials (SSEP) |
| Measure | Description | Time Frame |
|---|---|---|
| correlation of EP-sum-score (Σ-EP) and the Expanded Disability Status Scale (EDSS) | logistic regression model will be used to predict worsening in EDSS defined by a 1-point-change (0.5 if EDSS is 5.5 or higher) at year 3 | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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MS patients participating in the Swiss Multiple Sclerosis Cohort Study (SMSC), regardless of MS-specific treatment
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| Name | Affiliation | Role |
|---|---|---|
| Peter Fuhr, Prof. | Dep. of Neurology, Hospital of the University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Neurology, Hospital of the University of Basel | Basel | 4031 | Switzerland | |||
| Hopitaux universitaires de Genève |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35316624 | Background | Hardmeier M, Schlaeger R, Lascano AM, Toffolet L, Schindler C, Gobbi C, Lalive P, Kuhle J, Kappos L, Fuhr P. Prognostic biomarkers in primary progressive multiple sclerosis: Validating and scrutinizing multimodal evoked potentials. Clin Neurophysiol. 2022 May;137:152-158. doi: 10.1016/j.clinph.2022.02.019. Epub 2022 Mar 7. | |
| 33958567 |
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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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| primary progressive disease course (PPMS) | MS with a primary progressive disease course (PPMS) up to 15 years, EDSS: 2.0-6.5 inclusive EDSS: 6.0: Requires a walking aid - cane, crutch, etc. - to walk about 100m with or without resting 6.5: Requires two walking aids - pair of canes, crutches, etc. - to walk about 20m without resting. Multimodal evoked potentials (mmEP) assessments will take place at baseline, month 12 (from baseline), month 24 (from baseline) and month 36 (from baseline) |
|
| Geneva |
| Switzerland |
| Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano | Lugano | 6903 | Switzerland |
| Hardmeier M, Fuhr P. Multimodal Evoked Potentials as Candidate Prognostic and Response Biomarkers in Clinical Trials of Multiple Sclerosis. J Clin Neurophysiol. 2021 May 1;38(3):171-180. doi: 10.1097/WNP.0000000000000723. |
| 32793104 | Background | Hardmeier M, Schindler C, Kuhle J, Fuhr P. Validation of Quantitative Scores Derived From Motor Evoked Potentials in the Assessment of Primary Progressive Multiple Sclerosis: A Longitudinal Study. Front Neurol. 2020 Jul 24;11:735. doi: 10.3389/fneur.2020.00735. eCollection 2020. |
| 31069107 | Background | Hardmeier M, Jacques F, Albrecht P, Bousleiman H, Schindler C, Leocani L, Fuhr P. Multicentre assessment of motor and sensory evoked potentials in multiple sclerosis: reliability and implications for clinical trials. Mult Scler J Exp Transl Clin. 2019 May 1;5(2):2055217319844796. doi: 10.1177/2055217319844796. eCollection 2019 Apr-Jun. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |