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

Active, not recruiting
Conditions
Multiple Sclerosis
Registration Number
NCT03632473
Lead Sponsor
University Hospital, Basel, Switzerland
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

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
29
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
correlation of EP-sum-score (Σ-EP) and the Expanded Disability Status Scale (EDSS)3 years

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Dep. of Neurology, Hospital of the University of Basel

🇨🇭

Basel, Switzerland

Hopitaux universitaires de Genève

🇨🇭

Geneva, Switzerland

Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano

🇨🇭

Lugano, Switzerland

Dep. of Neurology, Hospital of the University of Basel
🇨🇭Basel, Switzerland

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