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
Name Time Method 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
Name Time Method
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