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Validation of Multimodal Evoked Potentials (mmEP) for Predicting Disease Progression in Multiple Sclerosis

Validation of Multimodal Evoked Potentials (mmEP) for Predicting Disease Progression in Multiple Sclerosis: Sub-study Within the Swiss Multiple Sclerosis Cohort (SMSC)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03632473
Acronym
SMSC
Enrollment
29
Registered
2018-08-15
Start date
2014-08-28
Completion date
2020-06-26
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multimodal Evoked potentials, Visual evoked potentials, Somato-sensory evoked potentials, Motor evoked potentials, Expanded Disability Status Scale (EDSS)

Brief summary

Utility of Multimodal Evoked potentials (mmEP) for monitoring disease course and prediction of progression at different stages of Multiple Sclerosis (MS) is investigated

Interventions

DIAGNOSTIC_TESTmultimodal evoked potentials (mmEP)

combination of visual evoked potentials (VEP) and motor evoked potentials (MEP) or the combination of VEP, MEP and somato-sensory evoked potentials (SSEP)

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* diagnosed with a clinically isolated syndrome (CIS) or MS with a relapsing-remitting (RRMS) or a primary progressive disease course (PPMS): * CIS: EDSS \<= 5.5 within six months of first clinical event * early RRMS: EDSS: \<= 3.5 disease course of 5 up to 10 years * late RRMS: EDSS: 2.0-5.5 inclusive disease course of 5 to 15 years * PPMS: EDSS: 2.0-6.5 inclusive disease course up to 15 years * participation in the Swiss Multiple Sclerosis Cohort Study (SMSC) * mental ability to cooperate * written informed consent

Exclusion criteria

* alcohol or substance abuse * progressive disease other than Multiple Sclerosis * psychiatric disorder requiring a treatment by a psychiatrist * patients with movable metal implants, e.g. pace-maker, stents, deep brain stimulators etc.;(patients with jaw- or bone-fixed metal implants can be included)

Design outcomes

Primary

MeasureTime frameDescription
correlation of EP-sum-score (Σ-EP) and the Expanded Disability Status Scale (EDSS)3 yearslogistic 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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026